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 .
DETAILED ACTION
Response to Amendment
Applicant’s amendments and remarks submitted 04/30/2026 have been entered and considered, but are not found convincing. Claims 1, 3-4, 6, 9-10,12-13, 17, 19-20 have been amended. In summary, claims 1-20 are pending in this application. Applicant’s amendments have necessitated the new grounds of rejection set forth herein; according, this action is made final.
Response to Arguments
Title
Applicant has amended title to overcome the previous objection. The previous objection of title has been withdrawn.
Claim objection:
Applicant has amended claims 10, 12-13 to overcome the previous objection. The previous objection of claim10, 12-13 has been withdrawn.
Claim Rejection-35 USC §112(b)
Applicant has amended claims 10 to overcome the rejection under 35 USC §112(b) . The rejection of claims 10, 13 has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant's arguments with respect to independent claims have been considered but are moot because the rejection has been modified to address the newly added limitations. Examiner now relies on the reference Strommer_903.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “controller unit configured to” in claims 1-14.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
1. Claims 1-5, 10-12, 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over CHAO et al., IDS, U.S Patent Application Publication No.20200129142 (“CHAO”) in view of Strommer et al., IDS, U.S Patent Application Publication No.20110021903 (Strommer_903)
Regarding independent claim 1, CHAO teaches an image processing device (Fig.1, item 100) configured to cause a display (Fig.1, item 108) to display, based on tomographic data ([0093] FIG. 11B illustrates screen display 1100 of a live view during a pullback procedure in accordance with at least one embodiment of the present disclosure. A virtual venogram 500, acting as a roadmap in the live view 1100, automatically shows where the transducer array 124 is located within the body. In some embodiments, a co-registered X-ray, CAT scan, or fluoroscopy image may be used as a roadmap instead of or in addition to the virtual venogram 500. The screen display 1100 also includes a live tomographic IVUS image 1010. In addition, the screen display 1100 includes image setting controls 1120 (e.g., gain, field of view, etc.) acquired by a sensor (Fig.1, item 124; [0093] FIG. 11B illustrates screen display 1100 of a live view during a pullback procedure in accordance with at least one embodiment of the present disclosure. A virtual venogram 500, acting as a roadmap in the live view 1100, automatically shows where the transducer array 124 is located within the body. In some embodiments, a co-registered X-ray, CAT scan, or fluoroscopy image may be used as a roadmap instead of or in addition to the virtual venogram 500. The screen display 1100 also includes a live tomographic IVUS image 1010. In addition, the screen display 1100 includes image setting controls 1120 (e.g., gain, field of view, etc.).) moving in a lumen of a biological tissue (Figure 1, item 120), an image representing the biological tissue and to display a first element on a screen same as the image ([0094] FIG. 12 illustrates a screen display 1100 during pullback, e.g., during recording of the IVUS data, in accordance with at least one embodiment of the present disclosure. A current frame indicator 1215 shows where on the cartoon roadmap or virtual venogram 500 of the vasculature the transducer array 124 of the catheter 510 is presently located. Label presets 1220 are also provided (e.g., vasculature segment abbreviations such as CIV, EIV, CFV, etc.). The IVUS frames are automatically labeled based on image analysis. In this example, the current position of the transducer array has been identified as the exterior iliac vein 550, and so the EIV label preset 1220 is highlighted or illuminated. A pullback speed indicator 1230 provides guidance to the clinician or other user for a stable pullback speed. The pullback speed indicator 1230 can be a series of blocks that are filled based on the speed (e.g., more blocks indicate faster speed and fewer blocks indicate slower speed). A tomographic IVUS image 1010 shows the current frame, and an automatic label 1240 can be generated using image analysis with the label presets described with respect to the current frame indicator 1215, e.g., by the vasculature segment abbreviation. Bookmark thumbnails 1250 appear when the user presses the bookmark option and/or the label preset option. A direction indicator 1260 is also included, showing, e.g., the orientation or direction of movement of the transducer array. Anterior (A), posterior (P), medial (M), lateral (L), and/or other suitable direction labels can be used. The direction indicator can include a compass arrow that moves based on the direction of movement. Interesting anatomy 1270 (e.g., thrombus) within the IVUS image 1010 can be colored, shaded, and/or highlighted.”) the first element representing a current position of the sensor and being displaced as the sensor moves (see at least [0094] FIG. 12 illustrates a screen display 1100 during pullback, e.g., during recording of the IVUS data, in accordance with at least one embodiment of the present disclosure. A current frame indicator 1215 shows where on the cartoon roadmap or virtual venogram 500 of the vasculature the transducer array 124 of the catheter 510 is presently located. Label presets 1220 are also provided (e.g., vasculature segment abbreviations such as CIV, EIV, CFV, etc.). The IVUS frames are automatically labeled based on image analysis. In this example, the current position of the transducer array has been identified as the exterior iliac vein 550, and so the EIV label preset 1220 is highlighted or illuminated. A pullback speed indicator 1230 provides guidance to the clinician or other user for a stable pullback speed. The pullback speed indicator 1230 can be a series of blocks that are filled based on the speed (e.g., more blocks indicate faster speed and fewer blocks indicate slower speed). A tomographic IVUS image 1010 shows the current frame, and an automatic label 1240 can be generated using image analysis with the label presets described with respect to the current frame indicator 1215, e.g., by the vasculature segment abbreviation. Bookmark thumbnails 1250 appear when the user presses the bookmark option and/or the label preset option. A direction indicator 1260 is also included, showing, e.g., the orientation or direction of movement of the transducer array. Anterior (A), posterior (P), medial (M), lateral (L), and/or other suitable direction labels can be used. The direction indicator can include a compass arrow that moves based on the direction of movement. Interesting anatomy 1270 (e.g., thrombus) within the IVUS image 1010 can be colored, shaded, and/or highlighted.”), the image processing device (Figure 1, 100) comprising:
a control unit configured to cause the display ([0063] “The controller or processing system 106 may include a processing circuit having one or more processors in communication with memory and/or other suitable tangible computer readable storage media. The controller or processing system 106 may be configured to carry out one or more aspects of the present disclosure. In some embodiments, the processing system 106 and the monitor 108 are separate components. In other embodiments, the processing system 106 and the monitor 108 are integrated in a single component. For example, the system 100 can include a touch screen device, including a housing having a touch screen display and a processor. The system 100 can include any suitable input device, such as a touch sensitive pad or touch screen display, keyboard/mouse, joystick, button, etc., for a user to select options shown on the monitor 108. The processing system 106, the monitor 108, the input device, and/or combinations thereof can be referenced as a controller of the system 100. The controller can be in communication with the device 102, the PIM 104, the processing system 106, the monitor 108, the input device, and/or other components of the system 100.”) to display, upon receiving a user operation of requesting marking of the current position of the sensor, a second element, the second element being fixedly displayed on the screen at a position at time of the user operation while the first element representing the current position of the sensor continuing to move on the screen to update tomographic data (see at least [0094] FIG. 12 illustrates a screen display 1100 during pullback, e.g., during recording of the IVUS data, in accordance with at least one embodiment of the present disclosure. A current frame indicator 1215 shows where on the cartoon roadmap or virtual venogram 500 of the vasculature the transducer array 124 of the catheter 510 is presently located. Label presets 1220 are also provided (e.g., vasculature segment abbreviations such as CIV, EIV, CFV, etc.). The IVUS frames are automatically labeled based on image analysis. In this example, the current position of the transducer array has been identified as the exterior iliac vein 550, and so the EIV label preset 1220 is highlighted or illuminated. A pullback speed indicator 1230 provides guidance to the clinician or other user for a stable pullback speed. The pullback speed indicator 1230 can be a series of blocks that are filled based on the speed (e.g., more blocks indicate faster speed and fewer blocks indicate slower speed). A tomographic IVUS image 1010 shows the current frame, and an automatic label 1240 can be generated using image analysis with the label presets described with respect to the current frame indicator 1215, e.g., by the vasculature segment abbreviation. Bookmark thumbnails 1250 appear when the user presses the bookmark option and/or the label preset option. A direction indicator 1260 is also included, showing, e.g., the orientation or direction of movement of the transducer array. Anterior (A), posterior (P), medial (M), lateral (L), and/or other suitable direction labels can be used. The direction indicator can include a compass arrow that moves based on the direction of movement. Interesting anatomy 1270 (e.g., thrombus) within the IVUS image 1010 can be colored, shaded, and/or highlighted.” [0107] FIG. 22 is a screenshot of a pullback navigation and marking display 2200, in accordance with at least one embodiment of the present disclosure. The screen display 2200 includes a live tomographic IVUS image 1010, image longitudinal display (ILD) 1020, virtual venogram 500, pullback speed indicator 520, user instruction 2210, and labeling button 2220. In this example, the user instruction 2210 is instructing the user to click the labeling button 2220 when the pullback of the ultrasound transducer array 124 reaches the start of the common iliac vein. In some embodiments, this selection is optional, as the IVUS pullback virtual venogram system identifies the start and end of different vasculature segments automatically. In other embodiments, the IVUS pullback virtual venogram system permits the clinician or other user to select the marking of the start or end of a vasculature segment through voice, gesture, or other touch-free command, such that a non-sterile staff member is not needed to operate a keyboard, mouse, joystick, or other non-sterile input device.” [0109] FIG. 23 is a screenshot of a pullback navigation and marking display 2200, in accordance with at least one embodiment of the present disclosure. Visible are the live tomographic IVUS image 1010, image longitudinal display (ILD) 1020, virtual venogram 500, pullback speed indicator 520, one-line user instruction 2210, labeling button 2220, artery 2230 (no longer bifurcating but now joined into a single lumen), and bifurcating vein 2240. In this example, the common iliac vein (CIV) 540 has been marked and highlighted on the virtual venogram, indicating that this is the segment of the patient's vasculature presently occupied by the ultrasound imaging array 124. In this example, the right external iliac vein (EIV) 550 is marked in a different color (e.g., light gray) to indicate this is the next segment the imaging array 124 will enter. The rest of the right-leg vasculature 1720 is marked with dotted lines, to show that it is not currently involved in the pullback procedure, while the left leg vasculature is grayed out (e.g., displayed with a gray color close to the background color) to indicate that it will not be involved in the pullback procedure at all.”) Chao is understood to be silent on the remaining limitations of claim 1.
In the same field of endeavor, Strommer_903 teaches display a first element on a screen same as the image, the first element representing a current position of the sensor and being displaced as the sensor moves ([0044] The surgeon can visually confirm the location of the tip of probe catheter 162, by observing an image (not shown) of a radiopaque marker (not shown), located at the tip of probe catheter 162, on a real-time image (not shown) of heart 170 (e.g., a fluoroscope). Alternatively, the surgeon can confirm the location of the tip of probe catheter 162, by observing the representation of the tip of probe catheter 162, which processor 152 produces according to an output of MPS 154. On the other hand, the orientation of the tip of probe catheter 162 can be confirmed only according to the output of MPS 154. Further alternatively, instead of the confirmation by the surgeon, the processor can direct a user interface (not shown) coupled therewith, to notify the surgeon that the tip of the probe catheter is located at the target point, and is oriented at the predetermined orientation, for example, by producing an aural or visual output, and the like. Alternatively, instead of a manual navigation by the surgeon, an automatic navigation system coupled with the processor, can be employed for automatically maneuvering and navigating the probe catheter within the body of the patient, and within the left ventricle, according to a previously acquired topological map of the circulation system of the body of the patient. [0057] According to another aspect of the disclosed technique, the surgeon navigates a probe catheter to a plurality of known points within a heart chamber (i.e., also known as the cardiac chamber) of the heart of the patient, by visually observing the probe of the probe catheter and a representation of the position of the probe, at these known points, in respective images of the heart chamber. The probe catheter includes an MPS sensor close to the probe. The MPS which is coupled with the MPS sensor, is registered with the coordinate system of the image detector which detects a three-dimensional the image of the heart chamber. Therefore, the processor can determine the position of the probe at each of these points, and associate it with the respective heart parameter, as detected by the probe. In this manner, the processor can construct an electrophysiological map of the heart chamber. The three dimensional image can for example, be a computerized tomography generated image, which defines the inner surface of the cardiac heart chamber. The surgeon maneuvers the probe to known points on that inner surface, the MPS sensor confirms arrival at these known points and the probe measures a desired parameter (e.g., electric potential, temperature, pressure) at each of these points. After gathering enough information, the processor can generate a map of this parameter on the inner surface.”), the image processing device comprising: a second element together with the first element, the second element being fixed fixedly displayed on the screen at a position same as a first fixed position of the first element at time of the user operation while the first element representing the current position of the sensor continuing to move on the screen to update tomographic data ([0039] With reference to FIG. 1A, a processor 100 includes data respective of a model 102 of a representative heart (not shown). Model 102 includes data respective of the location of a plurality of target points 104, 106, and 108, within the representative heart. Each of target points 104, 106, and 108, is defined as a point within a typical heart, at which an electrophysiological parameter is to be measured. An image detector (not shown), acquires an unmarked image 110 of a heart (not shown) of a body (not shown) of a patient (not shown). Processor 100 registers unmarked image 110 with model 102, and produces marked image 112, by superimposing target points 104, 106, and 108, on unmarked image 110. Alternatively, a surgeon (not shown) can direct processor 100 to produce marked image 112, by manually marking target points 104, 106, and 108 on unmarked image 110, via a user interface (not shown), for example, based on the symptoms of the patient, a previous diagnosis of the patient, and the like. [0053] In procedure 264, it is confirmed that the tip of the probe catheter is located at the respective target point location, by comparing the currently detected location of the tip of the probe catheter, with the respective target point location. With reference to FIG. 1B, processor 152 compares the current location of the tip of probe catheter 162, according to an output of MPS 154, with the target point location of target point 108, according to marked image 112 (FIG. 1A), and determines whether the current location substantially matches the target point location [0061] With reference to FIG. 4C, the surgeon navigates probe catheter 302 within ventricle 304, to a known point 306, by observing probe 308 in two-dimensional real-time image 300, and a representation 310 of the position of probe 308 in three-dimensional image 400. The heart parameter measuring unit determines a heart parameter (e.g., electric potential) at point 306, according to an output of probe 308. The MPS determines the position of probe 308 at point 306, according to an output of the MPS sensor. The processor associates this heart parameter with the same position. [0062] With reference to FIGS. 4D and 4E, the surgeon navigates probe catheter 302 to known points 312 and 314, respectively, by observing respective representations 316 and 318 of the position of probe 308, in three-dimensional image 400. The surgeon can also observe probe 308 in two-dimensional real-time image 300. The surgeon continues to navigate probe catheter 302 within the heart chamber, to additional known points sufficient for the processor to construct an electrophysiological map the heart chamber.”)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of marking the location of an intravascular imaging probe during an IVUS pullback of CHAO with probe catheter is located at the respective point marked location as seen in Strommer_903 because this modification would construct an electrophysiological map of the heart chamber ([0062] of Strommer_903)
Thus, the combination of CHAO and Strommer_903 teaches an image processing device configured to cause a display to display, based on tomographic data acquired by a sensor moving in a lumen of a biological tissue, an image representing the biological tissue and to display a first element on a screen same as the image, the first element representing a current position of the sensor and being displaced as the sensor moves, the image processing device comprising: a control unit configured to cause the display to display, upon receiving a user operation of requesting marking of the current position of the sensor, a second element together with the first element, the second element being fixed fixedly displayed on the screen at a position same as a first fixed position of the first element at time of the user operation while the first element representing the current position of the sensor continuing to move on the screen to update tomographic data.
Regarding claim 2, CHAO and Strommer_903 teach the image processing device according to claim 1, wherein the control unit is configured to set a color of the second element to a color different from a color of the first element (see at least [0074] of CHAO “ FIGS. 5-9 illustrate screen displays providing the guidance to the clinician during a IVUS pullback in peripheral vasculature. The screen displays advantageously provide a user with additional clarity to more clearly visualize aspects of deep venous disease. The screen displays perform several functions, including highlighting the segments of the vasculature, labeling the segments, and color coding or otherwise highlighting/distinguishing the segments and/or neighboring anatomy. The screen displays also automatically provide reference and compression measures (e.g., cross-sectional lumen area, diameter, etc.) within each of the segments. Segments meeting certain criteria (e.g., greater than or equal to 50% difference between reference and compression measures) are colored, highlighted, bolded, or marked differently (e.g., colored red) to indicate a segment of clinical interest or concern. Additionally, the screen displays provide real time feedback for the user about pullback speed. The GUIs can also provide for image quality improvement by provided the ability to adjust contrast, gain, focus, and/or other image settings. Image quality can also be improved based on providing feedback to the user to reach the correct pullback speed to obtain sufficient amount of high quality IVUS data. The screen displays provide: map to anatomy directly, immediate live values (reference, compression measurements), color coded segment highlights, pullback speed gauge (guidance). where color codes are used for various elements; [0083] In this example, a reference value 746 and compression value 748 associated with the CIV segment 540 are automatically provided on the screen display as the transducer array 124 moves within the vasculature. For example, the compression value 748 may be a numerical value of the cross-sectional lumen area for the particular patient, or a % compression value. In that regard, the compression value is automatically calculated based on the obtained IVUS data and then output to the screen display adjacent to the virtual venogram 500. In this example, the CIV segment 540 is colored based on the comparison between the reference value and the compression value. For example, comparison can be a ratio of the compression value 748 and the reference value 746 (e.g., compression value divided by reference value). In this example, the CIV segment 540 is colored differently than the IVC segment 540. For example, when the compression value 748 is less than 50% of the reference value 746, the segment can be colored in a second color (e.g., green) to indicate that the amount of compression is potentially harmful to the patient. Different colorings, shadings, highlighting can be used for the comparison of the reference value 746 and compression value 748 (e.g., different colors for greater than 50%, less than 50%, between 0% and 25%, between 25 and 50%, between 50% and 75%, between 75% and 100% ); [0061-0062] of Strommer_903). In addition, the same motivation is used as the rejection for claim 1.
Regarding claim 3, CHAO and Strommer_903 teach the image processing device according to claim 1, wherein the control unit is configured to move the sensor to a position corresponding to a the first fixed position of the second element upon receiving an operation of requesting movement of the sensor to the position corresponding to the first fixed position of the second element (see at least [0094] see at least[0107] - [0109] of CHAO “FIG. 23 is a screenshot of a pullback navigation and marking display 2200, in accordance with at least one embodiment of the present disclosure. Visible are the live tomographic IVUS image 1010, image longitudinal display (ILD) 1020, virtual venogram 500, pullback speed indicator 520, one-line user instruction 2210, labeling button 2220, artery 2230 (no longer bifurcating but now joined into a single lumen), and bifurcating vein 2240. In this example, the common iliac vein (CIV) 540 has been marked and highlighted on the virtual venogram, indicating that this is the segment of the patient's vasculature presently occupied by the ultrasound imaging array 124. In this example, the right external iliac vein (EIV) 550 is marked in a different color (e.g., light gray) to indicate this is the next segment the imaging array 124 will enter. The rest of the right-leg vasculature 1720 is marked with dotted lines, to show that it is not currently involved in the pullback procedure, while the left leg vasculature is grayed out (e.g., displayed with a gray color close to the background color) to indicate that it will not be involved in the pullback procedure at all; [0061] of Strommer_903 “ With reference to FIG. 4C, the surgeon navigates probe catheter 302 within ventricle 304, to a known point 306, by observing probe 308 in two-dimensional real-time image 300, and a representation 310 of the position of probe 308 in three-dimensional image 400. The heart parameter measuring unit determines a heart parameter (e.g., electric potential) at point 306, according to an output of probe 308. The MPS determines the position of probe 308 at point 306, according to an output of the MPS sensor. The processor associates this heart parameter with the same position. [0062] With reference to FIGS. 4D and 4E, the surgeon navigates probe catheter 302 to known points 312 and 314, respectively, by observing respective representations 316 and 318 of the position of probe 308, in three-dimensional image 400. The surgeon can also observe probe 308 in two-dimensional real-time image 300. The surgeon continues to navigate probe catheter 302 within the heart chamber, to additional known points sufficient for the processor to construct an electrophysiological map the heart chamber.”) In addition, the same motivation is used as the rejection for claim 1.
Regarding claim 4, CHAO and Strommer_903 teach the image processing device according to claim 1, wherein the control unit is configured to cause the display to display, upon receiving the user operation again, a third element together with the first element and the second element, the third element being fixed at a second fixed position same as a position of the first element at time of the user operation performed again (see at least see at least[0107] - [0109] of CHAO “FIG. 23 is a screenshot of a pullback navigation and marking display 2200, in accordance with at least one embodiment of the present disclosure. Visible are the live tomographic IVUS image 1010, image longitudinal display (ILD) 1020, virtual venogram 500, pullback speed indicator 520, one-line user instruction 2210, labeling button 2220, artery 2230 (no longer bifurcating but now joined into a single lumen), and bifurcating vein 2240. In this example, the common iliac vein (CIV) 540 has been marked and highlighted on the virtual venogram, indicating that this is the segment of the patient's vasculature presently occupied by the ultrasound imaging array 124. In this example, the right external iliac vein (EIV) 550 is marked in a different color (e.g., light gray) to indicate this is the next segment the imaging array 124 will enter. The rest of the right-leg vasculature 1720 is marked with dotted lines, to show that it is not currently involved in the pullback procedure, while the left leg vasculature is grayed out (e.g., displayed with a gray color close to the background color) to indicate that it will not be involved in the pullback procedure at all.; [0061] of Strommer_903 “ With reference to FIG. 4C, the surgeon navigates probe catheter 302 within ventricle 304, to a known point 306, by observing probe 308 in two-dimensional real-time image 300, and a representation 310 of the position of probe 308 in three-dimensional image 400. The heart parameter measuring unit determines a heart parameter (e.g., electric potential) at point 306, according to an output of probe 308. The MPS determines the position of probe 308 at point 306, according to an output of the MPS sensor. The processor associates this heart parameter with the same position. [0062] With reference to FIGS. 4D and 4E, the surgeon navigates probe catheter 302 to known points 312 and 314, respectively, by observing respective representations 316 and 318 of the position of probe 308, in three-dimensional image 400. The surgeon can also observe probe 308 in two-dimensional real-time image 300. The surgeon continues to navigate probe catheter 302 within the heart chamber, to additional known points sufficient for the processor to construct an electrophysiological map the heart chamber.”) In addition, the same motivation is used as the rejection for claim 1.
Regarding claim 5, CHAO and Strommer_903 teach the image processing device according to claim 4, wherein the control unit is configured to set a color of the third element to a color different from the color of the second element (see at least [0074] of CHAO “ FIGS. 5-9 illustrate screen displays providing the guidance to the clinician during a IVUS pullback in peripheral vasculature. The screen displays advantageously provide a user with additional clarity to more clearly visualize aspects of deep venous disease. The screen displays perform several functions, including highlighting the segments of the vasculature, labeling the segments, and color coding or otherwise highlighting/distinguishing the segments and/or neighboring anatomy. The screen displays also automatically provide reference and compression measures (e.g., cross-sectional lumen area, diameter, etc.) within each of the segments. Segments meeting certain criteria (e.g., greater than or equal to 50% difference between reference and compression measures) are colored, highlighted, bolded, or marked differently (e.g., colored red) to indicate a segment of clinical interest or concern. Additionally, the screen displays provide real time feedback for the user about pullback speed. The GUIs can also provide for image quality improvement by provided the ability to adjust contrast, gain, focus, and/or other image settings. Image quality can also be improved based on providing feedback to the user to reach the correct pullback speed to obtain sufficient amount of high quality IVUS data. The screen displays provide: map to anatomy directly, immediate live values (reference, compression measurements), color coded segment highlights, pullback speed gauge (guidance). where color codes are used for various elements; [0083] In this example, a reference value 746 and compression value 748 associated with the CIV segment 540 are automatically provided on the screen display as the transducer array 124 moves within the vasculature. For example, the compression value 748 may be a numerical value of the cross-sectional lumen area for the particular patient, or a % compression value. In that regard, the compression value is automatically calculated based on the obtained IVUS data and then output to the screen display adjacent to the virtual venogram 500. In this example, the CIV segment 540 is colored based on the comparison between the reference value and the compression value. For example, comparison can be a ratio of the compression value 748 and the reference value 746 (e.g., compression value divided by reference value). In this example, the CIV segment 540 is colored differently than the IVC segment 540. For example, when the compression value 748 is less than 50% of the reference value 746, the segment can be colored in a second color (e.g., green) to indicate that the amount of compression is potentially harmful to the patient. Different colorings, shadings, highlighting can be used for the comparison of the reference value 746 and compression value 748 (e.g., different colors for greater than 50%, less than 50%, between 0% and 25%, between 25 and 50%, between 50% and 75%, between 75% and 100%”; [0061-0062] of Strommer_903).In addition, the same motivation is used as the rejection for claim 1.
Regarding claim 10, CHAO and Strommer_903 teach the image processing device according to claim 4, wherein the control unit is configured to set a color of a region between a cross section corresponding to the first fixed position of the second element and a cross section corresponding to the second fixed position of the third element to a color different from a color of an adjacent region in a three-dimensional image (see at least [0048] of Chao “Understanding what artery or vessel segment a particular IVUS frame belongs to can be challenging and time consuming, especially because physicians see only the cross-sectional IVUS images and the reconstructed longitudinal view (image longitudinal display or ILD) on the dedicated IVUS screen, without any anatomical reference (bony landmarks) to which they can refer. To understand the position of the IVUS probe with respect to the patient's anatomy, physicians currently look at the fluoroscopy image during pullback, which lies on another screen. Moreover, during peripheral vascular interventions, the anatomical references for the segments' boundaries are confluences and branches with other vessels, which physicians and other users recognize on IVUS while doing pullbacks and on LIVE mode, and that they must mentally memorize. Clinicians may also call out regions of interest to their aides who may be less expert. The IVUS pullback virtual venogram system overcomes the lack of reference landmarks and displays the relative position of an IVUS frame, making IVUS image interpretation easier. The IVUS pullback virtual venogram system depicts this information in one simple, stylized anatomical visualization, which helps image interpretation after completion of a pullback, and provides a contextual visualization of the bookmarked frames. The IVUS pullback virtual venogram system lessens the staff-dependency of vascular surgeons. On completion of the pullback, the IVUS measurement results are automatically plotted on the IVUS pullback virtual venogram system in an easy-to-interpret way. [0109] “FIG. 23 is a screenshot of a pullback navigation and marking display 2200, in accordance with at least one embodiment of the present disclosure. Visible are the live tomographic IVUS image 1010, image longitudinal display (ILD) 1020, virtual venogram 500, pullback speed indicator 520, one-line user instruction 2210, labeling button 2220, artery 2230 (no longer bifurcating but now joined into a single lumen), and bifurcating vein 2240. In this example, the common iliac vein (CIV) 540 has been marked and highlighted on the virtual venogram, indicating that this is the segment of the patient's vasculature presently occupied by the ultrasound imaging array 124. In this example, the right external iliac vein (EIV) 550 is marked in a different color (e.g., light gray) to indicate this is the next segment the imaging array 124 will enter. The rest of the right-leg vasculature 1720 is marked with dotted lines, to show that it is not currently involved in the pullback procedure, while the left leg vasculature is grayed out (e.g., displayed with a gray color close to the background color) to indicate that it will not be involved in the pullback procedure at all”; [0061-0062] of Strommer_903) In addition, the same motivation is used as the rejection for claim 1.
Regarding claim 11, CHAO and Strommer_903 teach the image processing device according to claim 1, wherein the control unit is configured to combine a graphic element group that is an element group including the first element and the second element (see at least [0109] of CHAO “FIG. 23 is a screenshot of a pullback navigation and marking display 2200, in accordance with at least one embodiment of the present disclosure. Visible are the live tomographic IVUS image 1010, image longitudinal display (ILD) 1020, virtual venogram 500, pullback speed indicator 520, one-line user instruction 2210, labeling button 2220, artery 2230 (no longer bifurcating but now joined into a single lumen), and bifurcating vein 2240. In this example, the common iliac vein (CIV) 540 has been marked and highlighted on the virtual venogram, indicating that this is the segment of the patient's vasculature presently occupied by the ultrasound imaging array 124. In this example, the right external iliac vein (EIV) 550 is marked in a different color (e.g., light gray) to indicate this is the next segment the imaging array 124 will enter. The rest of the right-leg vasculature 1720 is marked with dotted lines, to show that it is not currently involved in the pullback procedure, while the left leg vasculature is grayed out (e.g., displayed with a gray color close to the background color) to indicate that it will not be involved in the pullback procedure at all”; [0059-0062] as shown in Figs 4A-4E of Strommer_903 ) and an elongated graphic element representing a movement range of the sensor ([0101-0104] of CHAO “FIG. 17 illustrates a screen display 1700 during pullback, e.g., during recording of IVUS data, in accordance with at least one embodiment of the present disclosure. On the left side of the screen display, a roadmap image, co-registered external image, or virtual venogram 500 of the vasculature is shown. A portion 1710 of the vasculature 1720 from which IVUS data has already been collected is highlighted, colored, and/or shaded…”[0107-0109];reference numeral “1020” in Fig.22 and Fig.23 showing long graphic element indicating a movement range of a sensor”) and to cause the display to display the graphic element group and the elongated graphic element (see at least [0107-0109];reference numeral “1020” in Fig.22 and Fig.23 showing long graphic element indicating a movement range of a sensor, [0059-0062] as shown in Figs 4A-4E of Strommer_903. Thus, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify displaying long graphic element indicating a movement range of a sensor CHAO with including displaying navigates probe catheter 302 to marked points of Strommer_903 because this modification would achieve the expected benefits of providing more attention for user.) In addition, the same motivation is used as the rejection for claim 1.
Regarding claim 12, CHAO and Strommer_903 teach the image processing device according to claim 11, wherein the control unit is configured to cause the display to display the elongated graphic element in a direction in which a longitudinal axis direction of the elongated graphic element is parallel to a longitudinal direction of the lumen in a three-dimensional image (see at least [0101-0104]; [0107-0109];reference numeral “1020” in Fig.22 and Fig.23 of CHAO showing long graphic element indicating a movement range of a sensor”; 0059-0062] as shown in Figs 4A-4E of Strommer_903. Thus, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify displaying long graphic element indicating a movement range of a sensor CHAO with including displaying navigates probe catheter 302 to marked points of Strommer_903 because this modification would achieve the expected benefits of providing more attention for user.) In addition, the same motivation is used as the rejection for claim 1.
Regarding claim 14, CHAO and Strommer_903 teach the image processing device according to claim 1, wherein the control unit is configured to receive an operation of pressing one or more predetermined keys as the user operation (see at least [0094] of CHAO “FIG. 12 illustrates a screen display 1100 during pullback, e.g., during recording of the IVUS data, in accordance with at least one embodiment of the present disclosure. A current frame indicator 1215 shows where on the cartoon roadmap or virtual venogram 500 of the vasculature the transducer array 124 of the catheter 510 is presently located. Label presets 1220 are also provided (e.g., vasculature segment abbreviations such as CIV, EIV, CFV, etc.). The IVUS frames are automatically labeled based on image analysis. In this example, the current position of the transducer array has been identified as the exterior iliac vein 550, and so the EIV label preset 1220 is highlighted or illuminated. A pullback speed indicator 1230 provides guidance to the clinician or other user for a stable pullback speed. The pullback speed indicator 1230 can be a series of blocks that are filled based on the speed (e.g., more blocks indicate faster speed and fewer blocks indicate slower speed). A tomographic IVUS image 1010 shows the current frame, and an automatic label 1240 can be generated using image analysis with the label presets described with respect to the current frame indicator 1215, e.g., by the vasculature segment abbreviation. Bookmark thumbnails 1250 appear when the user presses the bookmark option and/or the label preset option. A direction indicator 1260 is also included, showing, e.g., the orientation or direction of movement of the transducer array. Anterior (A), posterior (P), medial (M), lateral (L), and/or other suitable direction labels can be used. The direction indicator can include a compass arrow that moves based on the direction of movement. Interesting anatomy 1270 (e.g., thrombus) within the IVUS image 1010 can be colored, shaded, and/or highlighted.”; [0107] FIG. 22 is a screenshot of a pullback navigation and marking display 2200, in accordance with at least one embodiment of the present disclosure. The screen display 2200 includes a live tomographic IVUS image 1010, image longitudinal display (ILD) 1020, virtual venogram 500, pullback speed indicator 520, user instruction 2210, and labeling button 2220. In this example, the user instruction 2210 is instructing the user to click the labeling button 2220 when the pullback of the ultrasound transducer array 124 reaches the start of the common iliac vein. In some embodiments, this selection is optional, as the IVUS pullback virtual venogram system identifies the start and end of different vasculature segments automatically. In other embodiments, the IVUS pullback virtual venogram system permits the clinician or other user to select the marking of the start or end of a vasculature segment through voice, gesture, or other touch-free command, such that a non-sterile staff member is not needed to operate a keyboard, mouse, joystick, or other non-sterile input device.”)
Regarding claim 15, CHAO and Strommer_903 teach an image processing system (Fig. 1 of CHAO) comprising: the image processing device according to claim 1 (as discussed above); and a probe including the sensor ([0120] of CHAO “In step 2490, if an appropriate user input has been selected, the processing system 106 provides guidance to the clinician regarding movements of the intravascular imaging probe controls 104 that may be required to advance or retract the probe 102 to a desired location within the patient's body, or to mark the start or end of a given vascular segment, or to start or stop recording. Such guidance may be determined through conventional techniques (e.g., database lookup) or through learning-based techniques”; [0067] The external imaging system 132 can be configured to obtain x-ray, radiographic, angiographic/venographic (e.g., with contrast), and/or fluoroscopic (e.g., without contrast) images of the body of a patient (including the vessel 120). External imaging system 132 may also be configured to obtain computed tomography images of the body of patient (including the vessel 120).” The external imaging system 132 may include an external ultrasound probe configured to obtain ultrasound images of the body of the patient (including the vessel 120) while positioned outside the body. In some embodiments, the system 100 includes other imaging modality systems (e.g., MRI) to obtain images of the body of the patient (including the vessel 120). The processing system 106 can utilize the images of the body of the patient in conjunction with the intraluminal images obtained by the intraluminal device 102.”; [0017] of Strommer_903 “The MPS is registered with an image detector, wherein the image detector detects the image of the heart. The probe catheter is navigated to a plurality of points within the heart chamber, according to a representation of the position of an electrophysiological probe located at the tip of the probe catheter, in the image. The probe catheter includes an MPS sensor in the vicinity of the electrophysiological probe. The MPS sensor is coupled with the MPS. The MPS sensor detects the position. The heart parameter is detected at each of the points, by the electrophysiological probe. The position at each of the points, is determined according to an output of the MPS sensor. An electrophysiological map of the heart chamber is constructed, according to a plurality of pairs of the heart parameters and the respective positions.) In addition, the same motivation is used as the rejection for claim 1.
Regarding claim 16, CHAO and Strommer_903 teach the image processing system according to claim 15, further comprising: the display (CHAO: Fig 1, item 108, [0060] The PIM 104 transfers the received echo signals to the processing system 106 where the ultrasound image (including the flow information) is reconstructed and displayed on the monitor 108. The console or processing system 106 can include a processor and a memory. The processing system 106 may be operable to facilitate the features of the intraluminal imaging system 100 described herein. For example, the processor can execute computer readable instructions stored on the non-transitory tangible computer readable medium.”, Figs 5-23.)
Regarding independent claim 17, CHAO teaches an image display method of causing a display (Fig.1, item 108) to display, based on tomographic data acquired by a sensor moving in a lumen of a biological tissue (see at least [0093] FIG. 11B illustrates screen display 1100 of a live view during a pullback procedure in accordance with at least one embodiment of the present disclosure. A virtual venogram 500, acting as a roadmap in the live view 1100, automatically shows where the transducer array 124 is located within the body. In some embodiments, a co-registered X-ray, CAT scan, or fluoroscopy image may be used as a roadmap instead of or in addition to the virtual venogram 500. The screen display 1100 also includes a live tomographic IVUS image 1010. In addition, the screen display 1100 includes image setting controls 1120 (e.g., gain, field of view, etc.).), an image representing the biological tissue and display a first element on a screen same as the image, the first element representing a current position of the sensor and being displaced as the sensor moves (see at least [0094] FIG. 12 illustrates a screen display 1100 during pullback, e.g., during recording of the IVUS data, in accordance with at least one embodiment of the present disclosure. A current frame indicator 1215 shows where on the cartoon roadmap or virtual venogram 500 of the vasculature the transducer array 124 of the catheter 510 is presently located. Label presets 1220 are also provided (e.g., vasculature segment abbreviations such as CIV, EIV, CFV, etc.). The IVUS frames are automatically labeled based on image analysis. In this example, the current position of the transducer array has been identified as the exterior iliac vein 550, and so the EIV label preset 1220 is highlighted or illuminated. A pullback speed indicator 1230 provides guidance to the clinician or other user for a stable pullback speed. The pullback speed indicator 1230 can be a series of blocks that are filled based on the speed (e.g., more blocks indicate faster speed and fewer blocks indicate slower speed). A tomographic IVUS image 1010 shows the current frame, and an automatic label 1240 can be generated using image analysis with the label presets described with respect to the current frame indicator 1215, e.g., by the vasculature segment abbreviation. Bookmark thumbnails 1250 appear when the user presses the bookmark option and/or the label preset option. A direction indicator 1260 is also included, showing, e.g., the orientation or direction of movement of the transducer array. Anterior (A), posterior (P), medial (M), lateral (L), and/or other suitable direction labels can be used. The direction indicator can include a compass arrow that moves based on the direction of movement. Interesting anatomy 1270 (e.g., thrombus) within the IVUS image 1010 can be colored, shaded, and/or highlighted.”), the image display method comprising:
receiving a user operation of requesting marking of the current position of the sensor (see at least [0094] FIG. 12; [0107] FIG. 22 is a screenshot of a pullback navigation and marking display 2200, in accordance with at least one embodiment of the present disclosure. The screen display 2200 includes a live tomographic IVUS image 1010, image longitudinal display (ILD) 1020, virtual venogram 500, pullback speed indicator 520, user instruction 2210, and labeling button 2220. In this example, the user instruction 2210 is instructing the user to click the labeling button 2220 when the pullback of the ultrasound transducer array 124 reaches the start of the common iliac vein. In some embodiments, this selection is optional, as the IVUS pullback virtual venogram system identifies the start and end of different vasculature segments automatically. In other embodiments, the IVUS pullback virtual venogram system permits the clinician or other user to select the marking of the start or end of a vasculature segment through voice, gesture, or other touch-free command, such that a non-sterile staff member is not needed to operate a keyboard, mouse, joystick, or other non-sterile input device.” ); and causing the display to display a second element ([0109] FIG. 23 is a screenshot of a pullback navigation and marking display 2200, in accordance with at least one embodiment of the present disclosure. Visible are the live tomographic IVUS image 1010, image longitudinal display (ILD) 1020, virtual venogram 500, pullback speed indicator 520, one-line user instruction 2210, labeling button 2220, artery 2230 (no longer bifurcating but now joined into a single lumen), and bifurcating vein 2240. In this example, the common iliac vein (CIV) 540 has been marked and highlighted on the virtual venogram, indicating that this is the segment of the patient's vasculature presently occupied by the ultrasound imaging array 124. In this example, the right external iliac vein (EIV) 550 is marked in a different color (e.g., light gray) to indicate this is the next segment the imaging array 124 will enter. The rest of the right-leg vasculature 1720 is marked with dotted lines, to show that it is not currently involved in the pullback procedure, while the left leg vasculature is grayed out (e.g., displayed with a gray color close to the background color) to indicate that it will not be involved in the pullback procedure at all.”) causing the display to display a second element together with the first element, the second element being fixed fixedly displayed on the screen at a position at time of the user operation while the first element representing the current position of the sensor continuing to move on the screen to update tomographic data (see at least [0109] FIG. 23 is a screenshot of a pullback navigation and marking display 2200, in accordance with at least one embodiment of the present disclosure. Visible are the live tomographic IVUS image 1010, image longitudinal display (ILD) 1020, virtual venogram 500, pullback speed indicator 520, one-line user instruction 2210, labeling button 2220, artery 2230 (no longer bifurcating but now joined into a single lumen), and bifurcating vein 2240. In this example, the common iliac vein (CIV) 540 has been marked and highlighted on the virtual venogram, indicating that this is the segment of the patient's vasculature presently occupied by the ultrasound imaging array 124. In this example, the right external iliac vein (EIV) 550 is marked in a different color (e.g., light gray) to indicate this is the next segment the imaging array 124 will enter. The rest of the right-leg vasculature 1720 is marked with dotted lines, to show that it is not currently involved in the pullback procedure, while the left leg vasculature is grayed out (e.g., displayed with a gray color close to the background color) to indicate that it will not be involved in the pullback procedure at all.) CHAO are understood to be silent on the remaining limitations of claim 17.
In the same field of endeavor, Strommer_903 teaches display a first element on a screen same as the image, the first element representing a current position of the sensor and being displaced as the sensor moves ([0044] The surgeon can visually confirm the location of the tip of probe catheter 162, by observing an image (not shown) of a radiopaque marker (not shown), located at the tip of probe catheter 162, on a real-time image (not shown) of heart 170 (e.g., a fluoroscope). Alternatively, the surgeon can confirm the location of the tip of probe catheter 162, by observing the representation of the tip of probe catheter 162, which processor 152 produces according to an output of MPS 154. On the other hand, the orientation of the tip of probe catheter 162 can be confirmed only according to the output of MPS 154. Further alternatively, instead of the confirmation by the surgeon, the processor can direct a user interface (not shown) coupled therewith, to notify the surgeon that the tip of the probe catheter is located at the target point, and is oriented at the predetermined orientation, for example, by producing an aural or visual output, and the like. Alternatively, instead of a manual navigation by the surgeon, an automatic navigation system coupled with the processor, can be employed for automatically maneuvering and navigating the probe catheter within the body of the patient, and within the left ventricle, according to a previously acquired topological map of the circulation system of the body of the patient. [0057] According to another aspect of the disclosed technique, the surgeon navigates a probe catheter to a plurality of known points within a heart chamber (i.e., also known as the cardiac chamber) of the heart of the patient, by visually observing the probe of the probe catheter and a representation of the position of the probe, at these known points, in respective images of the heart chamber. The probe catheter includes an MPS sensor close to the probe. The MPS which is coupled with the MPS sensor, is registered with the coordinate system of the image detector which detects a three-dimensional the image of the heart chamber. Therefore, the processor can determine the position of the probe at each of these points, and associate it with the respective heart parameter, as detected by the probe. In this manner, the processor can construct an electrophysiological map of the heart chamber. The three dimensional image can for example, be a computerized tomography generated image, which defines the inner surface of the cardiac heart chamber. The surgeon maneuvers the probe to known points on that inner surface, the MPS sensor confirms arrival at these known points and the probe measures a desired parameter (e.g., electric potential, temperature, pressure) at each of these points. After gathering enough information, the processor can generate a map of this parameter on the inner surface.”), the image display method comprising: causing the display to display a second element together with the first element, the second element being fixed fixedly displayed on the screen at a position same as a first fixed position of the first element at time of the user operation while the first element representing the current position of the sensor continuing to move on the screen to update tomographic data ([0039] With reference to FIG. 1A, a processor 100 includes data respective of a model 102 of a representative heart (not shown). Model 102 includes data respective of the location of a plurality of target points 104, 106, and 108, within the representative heart. Each of target points 104, 106, and 108, is defined as a point within a typical heart, at which an electrophysiological parameter is to be measured. An image detector (not shown), acquires an unmarked image 110 of a heart (not shown) of a body (not shown) of a patient (not shown). Processor 100 registers unmarked image 110 with model 102, and produces marked image 112, by superimposing target points 104, 106, and 108, on unmarked image 110. Alternatively, a surgeon (not shown) can direct processor 100 to produce marked image 112, by manually marking target points 104, 106, and 108 on unmarked image 110, via a user interface (not shown), for example, based on the symptoms of the patient, a previous diagnosis of the patient, and the like. [0053] In procedure 264, it is confirmed that the tip of the probe catheter is located at the respective target point location, by comparing the currently detected location of the tip of the probe catheter, with the respective target point location. With reference to FIG. 1B, processor 152 compares the current location of the tip of probe catheter 162, according to an output of MPS 154, with the target point location of target point 108, according to marked image 112 (FIG. 1A), and determines whether the current location substantially matches the target point location [0061] With reference to FIG. 4C, the surgeon navigates probe catheter 302 within ventricle 304, to a known point 306, by observing probe 308 in two-dimensional real-time image 300, and a representation 310 of the position of probe 308 in three-dimensional image 400. The heart parameter measuring unit determines a heart parameter (e.g., electric potential) at point 306, according to an output of probe 308. The MPS determines the position of probe 308 at point 306, according to an output of the MPS sensor. The processor associates this heart parameter with the same position. [0062] With reference to FIGS. 4D and 4E, the surgeon navigates probe catheter 302 to known points 312 and 314, respectively, by observing respective representations 316 and 318 of the position of probe 308, in three-dimensional image 400. The surgeon can also observe probe 308 in two-dimensional real-time image 300. The surgeon continues to navigate probe catheter 302 within the heart chamber, to additional known points sufficient for the processor to construct an electrophysiological map the heart chamber.”) In addition, the same motivation is used as the rejection for claim 1.
Thus, the combination of CHAO and Strommer_903 teaches an image display method of causing a display to display, based on tomographic data acquired by a sensor moving in a lumen of a biological tissue, an image representing the biological tissue and display a first element on a screen same as the image, the first element representing a current position of the sensor and being displaced as the sensor moves, the image display method comprising: receiving a user operation of requesting marking of the current position of the sensor; and causing the display to display a second element together with the first element, the second element being fixed fixedly displayed on the screen at a position same as a first fixed position of the first element at time of the user operation while the first element representing the current position of the sensor continuing to move on the screen to update tomographic data.
Regarding claim 18, CHAO and Strommer_903 teach the image display method according to claim 17, further comprising: setting a color of the second element to a color different from a color of the first element (see at least [0074] of CHAO “ FIGS. 5-9 illustrate screen displays providing the guidance to the clinician during a IVUS pullback in peripheral vasculature. The screen displays advantageously provide a user with additional clarity to more clearly visualize aspects of deep venous disease. The screen displays perform several functions, including highlighting the segments of the vasculature, labeling the segments, and color coding or otherwise highlighting/distinguishing the segments and/or neighboring anatomy. The screen displays also automatically provide reference and compression measures (e.g., cross-sectional lumen area, diameter, etc.) within each of the segments. Segments meeting certain criteria (e.g., greater than or equal to 50% difference between reference and compression measures) are colored, highlighted, bolded, or marked differently (e.g., colored red) to indicate a segment of clinical interest or concern. Additionally, the screen displays provide real time feedback for the user about pullback speed. The GUIs can also provide for image quality improvement by provided the ability to adjust contrast, gain, focus, and/or other image settings. Image quality can also be improved based on providing feedback to the user to reach the correct pullback speed to obtain sufficient amount of high quality IVUS data. The screen displays provide: map to anatomy directly, immediate live values (reference, compression measurements), color coded segment highlights, pullback speed gauge (guidance). where color codes are used for various elements; [0083] In this example, a reference value 746 and compression value 748 associated with the CIV segment 540 are automatically provided on the screen display as the transducer array 124 moves within the vasculature. For example, the compression value 748 may be a numerical value of the cross-sectional lumen area for the particular patient, or a % compression value. In that regard, the compression value is automatically calculated based on the obtained IVUS data and then output to the screen display adjacent to the virtual venogram 500. In this example, the CIV segment 540 is colored based on the comparison between the reference value and the compression value. For example, comparison can be a ratio of the compression value 748 and the reference value 746 (e.g., compression value divided by reference value). In this example, the CIV segment 540 is colored differently than the IVC segment 540. For example, when the compression value 748 is less than 50% of the reference value 746, the segment can be colored in a second color (e.g., green) to indicate that the amount of compression is potentially harmful to the patient. Different colorings, shadings, highlighting can be used for the comparison of the reference value 746 and compression value 748 (e.g., different colors for greater than 50%, less than 50%, between 0% and 25%, between 25 and 50%, between 50% and 75%, between 75% and 100% ); [0061-0062] of Strommer_903). In addition, the same motivation is used as the rejection for claim 1.
Regarding claim 19, CHAO and Strommer_903 teach the image display method according to claim 17, further comprising: moving the sensor to a position corresponding to the first fixed position of the second element upon receiving an operation of requesting movement of the sensor to the position corresponding to the first fixed position of the second element (see at least [0094] see at least[0107] - [0109] of CHAO “FIG. 23 is a screenshot of a pullback navigation and marking display 2200, in accordance with at least one embodiment of the present disclosure. Visible are the live tomographic IVUS image 1010, image longitudinal display (ILD) 1020, virtual venogram 500, pullback speed indicator 520, one-line user instruction 2210, labeling button 2220, artery 2230 (no longer bifurcating but now joined into a single lumen), and bifurcating vein 2240. In this example, the common iliac vein (CIV) 540 has been marked and highlighted on the virtual venogram, indicating that this is the segment of the patient's vasculature presently occupied by the ultrasound imaging array 124. In this example, the right external iliac vein (EIV) 550 is marked in a different color (e.g., light gray) to indicate this is the next segment the imaging array 124 will enter. The rest of the right-leg vasculature 1720 is marked with dotted lines, to show that it is not currently involved in the pullback procedure, while the left leg vasculature is grayed out (e.g., displayed with a gray color close to the background color) to indicate that it will not be involved in the pullback procedure at all; [0061] of Strommer_903 “ With reference to FIG. 4C, the surgeon navigates probe catheter 302 within ventricle 304, to a known point 306, by observing probe 308 in two-dimensional real-time image 300, and a representation 310 of the position of probe 308 in three-dimensional image 400. The heart parameter measuring unit determines a heart parameter (e.g., electric potential) at point 306, according to an output of probe 308. The MPS determines the position of probe 308 at point 306, according to an output of the MPS sensor. The processor associates this heart parameter with the same position. [0062] With reference to FIGS. 4D and 4E, the surgeon navigates probe catheter 302 to known points 312 and 314, respectively, by observing respective representations 316 and 318 of the position of probe 308, in three-dimensional image 400. The surgeon can also observe probe 308 in two-dimensional real-time image 300. The surgeon continues to navigate probe catheter 302 within the heart chamber, to additional known points sufficient for the processor to construct an electrophysiological map the heart chamber.”) In addition, the same motivation is used as the rejection for claim 1.
Regarding independent claim 20, CHAO teaches non-transitory computer-readable medium storing an image processing program configured to cause a computer to execute processing ([0126] The memory 2564 may include a cache memory (e.g., a cache memory of the processor 2560), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read only memory (EPROM), electrically erasable programmable read only memory (EEPROM), flash memory, solid state memory device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory. In an embodiment, the memory 2564 includes a non-transitory computer-readable medium. The memory 2564 may store instructions 2566. The instructions 2566 may include instructions that, when executed by the processor 2560, cause the processor 2560 to perform the operations described herein. Instructions 2566 may also be referred to as code. The terms “instructions” and “code” should be interpreted broadly to include any type of computer-readable statement(s). For example, the terms “instructions” and “code” may refer to one or more programs, routines, sub-routines, functions, procedures, etc. “Instructions” and “code” may include a single computer-readable statement or many computer-readable statements”), the computer causing remaining limitations of claim 20 is similar scope to claim 1 and therefore rejected under the same rationale.
2. Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over CHAO et al., IDS, U.S Patent Application Publication No.20200129142 (“CHAO”) in view of Strommer et al., IDS, U.S Patent Application Publication No.20110021903 (Strommer_903) further in view of Strommer et al, IDS, U.S Patent Application Publication No.20060058647 (“Strommer_647”)
Regarding claim 6, CHAO and Strommer_903 teach the image processing device according to claim 4, wherein the control unit is configured to cause the display to display a fourth element together with the first element, the second element, and the third element, the fourth element being fixed at a third fixed position, the second element and the third element (see at least [0107] - [0109] of CHAO “FIG. 23 is a screenshot of a pullback navigation and marking display 2200, in accordance with at least one embodiment of the present disclosure. Visible are the live tomographic IVUS image 1010, image longitudinal display (ILD) 1020, virtual venogram 500, pullback speed indicator 520, one-line user instruction 2210, labeling button 2220, artery 2230 (no longer bifurcating but now joined into a single lumen), and bifurcating vein 2240. In this example, the common iliac vein (CIV) 540 has been marked and highlighted on the virtual venogram, indicating that this is the segment of the patient's vasculature presently occupied by the ultrasound imaging array 124. In this example, the right external iliac vein (EIV) 550 is marked in a different color (e.g., light gray) to indicate this is the next segment the imaging array 124 will enter. The rest of the right-leg vasculature 1720 is marked with dotted lines, to show that it is not currently involved in the pullback procedure, while the left leg vasculature is grayed out (e.g., displayed with a gray color close to the background color) to indicate that it will not be involved in the pullback procedure at all.”; [0061] of Strommer_903 “ With reference to FIG. 4C, the surgeon navigates probe catheter 302 within ventricle 304, to a known point 306, by observing probe 308 in two-dimensional real-time image 300, and a representation 310 of the position of probe 308 in three-dimensional image 400. The heart parameter measuring unit determines a heart parameter (e.g., electric potential) at point 306, according to an output of probe 308. The MPS determines the position of probe 308 at point 306, according to an output of the MPS sensor. The processor associates this heart parameter with the same position. [0062] With reference to FIGS. 4D and 4E, the surgeon navigates probe catheter 302 to known points 312 and 314, respectively, by observing respective representations 316 and 318 of the position of probe 308, in three-dimensional image 400. The surgeon can also observe probe 308 in two-dimensional real-time image 300. The surgeon continues to navigate probe catheter 302 within the heart chamber, to additional known points sufficient for the processor to construct an electrophysiological map the heart chamber.”) In addition, the same motivation is used as the rejection for claim 1. Both CHAO and Strommer_903 are understood to be silent on the remaining limitations of claim 6.
In the same field of endeavor, Strommer_647 teaches the fourth element being fixed at a position between the second element and the third element (see at least [0083] During the planning session, a respective one of the displays marks 116, 118 and 120 articulated by the user interface on an image of lumen 108. The operator can move marks 116, 118 and 120 together along the full length of the trajectory (e.g., trajectory 114 of FIG. 1B). Mark 118 designates the middle of the medical device, while marks 116 and 120 designate the rear end and the front end of the medical device, respectively. The system determines the distance between marks 116 and 120, according to the type (e.g., the size of stent) which the operator has selected.”)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of marking the location of an intravascular imaging probe during an IVUS pullback of CHAO and Strommer_903 with designating mark 118 the middle between marks 116 and 120 as seen in Strommer_647 because this modification would designates marks at the middle of the medical device, the rear end and the front end of the medical device ([0083] of Strommer_647 )
Thus, the combination of CHAO and Strommer_903, Strommer_647 teaches wherein the control unit is configured to cause the display to display a fourth element together with the first element, the second element, and the third element, the fourth element being fixed at a third fixed position between the second element and the third element.
Regarding claim 7, CHAO and Strommer_903, Strommer_647 teach the image processing device according to claim 6, wherein the control unit is configured to calculate an intermediate position between the second element and the third element as the position between the second element and the third element (see at least[0107] - [0109] of CHAO “FIG. 23 is a screenshot of a pullback navigation and marking display 2200, in accordance with at least one embodiment of the present disclosure. Visible are the live tomographic IVUS image 1010, image longitudinal display (ILD) 1020, virtual venogram 500, pullback speed indicator 520, one-line user instruction 2210, labeling button 2220, artery 2230 (no longer bifurcating but now joined into a single lumen), and bifurcating vein 2240. In this example, the common iliac vein (CIV) 540 has been marked and highlighted on the virtual venogram, indicating that this is the segment of the patient's vasculature presently occupied by the ultrasound imaging array 124. In this example, the right external iliac vein (EIV) 550 is marked in a different color (e.g., light gray) to indicate this is the next segment the imaging array 124 will enter. The rest of the right-leg vasculature 1720 is marked with dotted lines, to show that it is not currently involved in the pullback procedure, while the left leg vasculature is grayed out (e.g., displayed with a gray color close to the background color) to indicate that it will not be involved in the pullback procedure at all.”; [0061-0062] of Strommer_903; see at least [0083] During the planning session, a respective one of the displays displays marks 116, 118 and 120 articulated by the user interface on an image of lumen 108. The operator can move marks 116, 118 and 120 together along the full length of the trajectory (e.g., trajectory 114 of FIG. 1B). Mark 118 designates the middle of the medical device, while marks 116 and 120 designate the rear end and the front end of the medical device, respectively. The system determines the distance between marks 116 and 120, according to the type (e.g., the size of stent) which the operator has selected. Marks 116, 118 and 120 together, are locked-on to the trajectory, while being operative to travel along the trajectory. The operator designates the position of mark 118 along the trajectory where the medical device is to be delivered to. [0084] For simplicity, the medical device in the example set forth in FIGS. 2A, 2B, 3A, and 3B, is a stent. In this case, each of marks 116, 118, and 120 is a substantially straight line, which is substantially perpendicular to lumen 108. For example, marks 116 and 120 designate the two ends of the stent, while mark 118 designates the middle of the stent. Marks 116, 118, and 120 define the location of the stent in lumen 108, as well as the orientation thereof. The marking is performed via a user interface (not shown), such as a joystick, push button, pointing device (e.g., a mouse, stylus and digital tablet, track-ball, touch pad), and the like.[0199] An operator (not shown) inputs position data respective of the selected position, by designating marks 726, 728, and 730, on image 720, to processor 666, via user interface 664. Marks 726, 728, and 730 designate the selected position within lumen 722 toward which a medical device (not shown), is to be maneuvered. The medical device is located at the tip of a catheter 732 (FIG. 13). For example, mark 726 designates the position at which a front end of a stent (not shown), should be placed, mark 730 designates the position at which the rear end of the stent should be placed, and mark 728 designates the position at which the middle of, the stent should be placed. The operator inputs position data respective of the same selected position, by designating marks 802 (FIG. 14B), 804, and 806, on image 724, to processor 666, via user interface 664.) In addition, the same motivation is used as the rejection for claim 6.
Regarding claim 8, CHAO and Strommer_903, Strommer_647 teach the image processing device according to claim 6, wherein the control unit is configured to set a color of the fourth element to a color different from the color of the second element and the color of the third element (see at least [0074] of CHAO “ FIGS. 5-9 illustrate screen displays providing the guidance to the clinician during a IVUS pullback in peripheral vasculature. The screen displays advantageously provide a user with additional clarity to more clearly visualize aspects of deep venous disease. The screen displays perform several functions, including highlighting the segments of the vasculature, labeling the segments, and color coding or otherwise highlighting/distinguishing the segments and/or neighboring anatomy. The screen displays also automatically provide reference and compression measures (e.g., cross-sectional lumen area, diameter, etc.) within each of the segments. Segments meeting certain criteria (e.g., greater than or equal to 50% difference between reference and compression measures) are colored, highlighted, bolded, or marked differently (e.g., colored red) to indicate a segment of clinical interest or concern. Additionally, the screen displays provide real time feedback for the user about pullback speed. The GUIs can also provide for image quality improvement by provided the ability to adjust contrast, gain, focus, and/or other image settings. Image quality can also be improved based on providing feedback to the user to reach the correct pullback speed to obtain sufficient amount of high quality IVUS data. The screen displays provide: map to anatomy directly, immediate live values (reference, compression measurements), color coded segment highlights, pullback speed gauge (guidance). where color codes are used for various elements; [0083] In this example, a reference value 746 and compression value 748 associated with the CIV segment 540 are automatically provided on the screen display as the transducer array 124 moves within the vasculature. For example, the compression value 748 may be a numerical value of the cross-sectional lumen area for the particular patient, or a % compression value. In that regard, the compression value is automatically calculated based on the obtained IVUS data and then output to the screen display adjacent to the virtual venogram 500. In this example, the CIV segment 540 is colored based on the comparison between the reference value and the compression value. For example, comparison can be a ratio of the compression value 748 and the reference value 746 (e.g., compression value divided by reference value). In this example, the CIV segment 540 is colored differently than the IVC segment 540. For example, when the compression value 748 is less than 50% of the reference value 746, the segment can be colored in a second color (e.g., green) to indicate that the amount of compression is potentially harmful to the patient. Different colorings, shadings, highlighting can be used for the comparison of the reference value 746 and compression value 748 (e.g., different colors for greater than 50%, less than 50%, between 0% and 25%, between 25 and 50%, between 50% and 75%, between 75% and 100% ) [0061-0062] of Strommer_903; [0091] of Strommer_647 “ It is further noted that the operator can direct the system to either turn on or turn off the display of superposition of any of the marks, the representation of the position of the stent, the trajectory, or a combination thereof, via the user interface. Any attribute can be selected to represent the marks and the representation of the stent, as long as they are different, such as color, shape, size, and the like. However, a mark or a stent representation is displayed by the same attribute both in two-dimensional image 104 and three-dimensional image 106. For example, marks 116, 118, 120, 122, 124, and 126 are represented in green, features 128, 130, 132, and 134 are represented in blue, and trajectory 140 is represented in red.). In addition, the same motivation is used as the rejection for claim 6.
Regarding claim 9, CHAO and Strommer_903, Strommer_647 teach the image processing device according to claim 6, wherein the control unit is configured to move the sensor to a the third fixed position corresponding to a position of the fourth element upon receiving an operation of requesting movement of the sensor to the position corresponding to the third fixed position of the fourth element (see at least [0107] - [0109] of CHAO; [0061] of Strommer_903” With reference to FIG. 4C, the surgeon navigates probe catheter 302 within ventricle 304, to a known point 306, by observing probe 308 in two-dimensional real-time image 300, and a representation 310 of the position of probe 308 in three-dimensional image 400. The heart parameter measuring unit determines a heart parameter (e.g., electric potential) at point 306, according to an output of probe 308. The MPS determines the position of probe 308 at point 306, according to an output of the MPS sensor. The processor associates this heart parameter with the same position. [0062] With reference to FIGS. 4D and 4E, the surgeon navigates probe catheter 302 to known points 312 and 314, respectively, by observing respective representations 316 and 318 of the position of probe 308, in three-dimensional image 400. The surgeon can also observe probe 308 in two-dimensional real-time image 300. The surgeon continues to navigate probe catheter 302 within the heart chamber, to additional known points sufficient for the processor to construct an electrophysiological map the heart chamber.; [0083] of Strommer During the planning session, a respective one of the displays displays marks 116, 118 and 120 articulated by the user interface on an image of lumen 108. The operator can move marks 116, 118 and 120 together along the full length of the trajectory (e.g., trajectory 114 of FIG. 1B). Mark 118 designates the middle of the medical device, while marks 116 and 120 designate the rear end and the front end of the medical device, respectively. The system determines the distance between marks 116 and 120, according to the type (e.g., the size of stent) which the operator has selected. Marks 116, 118 and 120 together, are locked-on to the trajectory, while being operative to travel along the trajectory. The operator designates the position of mark 118 along the trajectory where the medical device is to be delivered to. [0211] “In procedure 846, a representation respective of the selected position is superimposed on the real-time navigation image, thereby enabling an operator to visually navigate the medical device toward the selected position. With reference to FIGS. 13 and 15A, processor 666 produces real-time superimposed two-dimensional image 760, by superimposing a representation of each of marks 808, 810, and 812 on a real-time two-dimensional image of lumen 722, of catheter 732, and of medical device 762. Thus, the operator can visually navigate medical device 762 toward the selected position, according to real-time superimposed two-dimensional image 760. [0212] According to another aspect of the disclosed technique, different trajectories of an MPS catheter within the lumen is determined, corresponding to different activity states of an organ of the patient, by moving the MPS catheter within the lumen. Each trajectory is defined in a three-dimensional MPS coordinate system, and is time-tagged with the corresponding activity state. Each trajectory is superimposed on a real-time two-dimensional image of the lumen, according to the activity state associated with the real-time two-dimensional image. This superimposed real-time two-dimensional which is associated with the organ timing signal detected by an organ timing signal monitor, is displayed on the display, thereby enabling the operator to mark the selected position on the superimposed real-time two-dimensional image. The operator, navigates the medical device to the selected position, either automatically or manually by employing the method of FIG. 5, as described herein above. Alternatively, the operator navigates the medical device to the selected position, visually, by employing the method of FIG. 17, as described herein above. ) In addition, the same motivation is used as the rejection for claim 6.
3. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over CHAO et al., IDS, U.S Patent Application Publication No.20200129142 (“CHAO”) in view of Strommer et al., IDS, U.S Patent Application Publication No.20110021903 (Strommer_903) further in view of further in view of Jiang, U.S Patent Application Publication No. 2014/0039294 (“Jiang”)
Regarding claim 13, CHAO and Strommer_903 teach the image processing device according to claim 1, wherein the control unit is configured to define the first element and the second element in a three-dimensional image that is the image( see at least Fig.12, Fig.13 of CHAO; [0059] of Strommer_903 “With reference to FIG. 4A, a 2D image detector (not shown) detects two-dimensional real-time image 300. A tomographic image detector detects three-dimensional image 400. The tomographic image detector detects three-dimensional image 400 prior to the medical operation on the patient. A probe catheter 302 is inserted into a left ventricle 304 of the heart of the patient. Probe catheter 302 is similar to probe catheter 162 as described herein above in connection with FIG. 1B, and includes an MPS sensor (not shown), and a probe 308 at the tip thereof. An MPS (not shown) is coupled with the MPS sensor and with a processor (not shown). A heart parameter measuring unit (not shown) is coupled with probe 308 and with the processor.”), the first element being defined as at least a voxel representing an inner surface of the biological tissue or a voxel adjacent to the voxel representing the inner surface and representing the lumen in a first voxel group corresponding to a position of the sensor, the second element being defined as at least a voxel representing the inner surface or a voxel adjacent to the voxel representing the inner surface and representing the lumen in a second voxel group corresponding to a position of the sensor at time of the user operation (Fig.12 of CHAO “[0094] FIG. 12 illustrates a screen display 1100 during pullback, e.g., during recording of the IVUS data, in accordance with at least one embodiment of the present disclosure. A current frame indicator 1215 shows where on the cartoon roadmap or virtual venogram 500 of the vasculature the transducer array 124 of the catheter 510 is presently located. Label presets 1220 are also provided (e.g., vasculature segment abbreviations such as CIV, EIV, CFV, etc.). The IVUS frames are automatically labeled based on image analysis. In this example, the current position of the transducer array has been identified as the exterior iliac vein 550, and so the EIV label preset 1220 is highlighted or illuminated. A pullback speed indicator 1230 provides guidance to the clinician or other user for a stable pullback speed. The pullback speed indicator 1230 can be a series of blocks that are filled based on the speed (e.g., more blocks indicate faster speed and fewer blocks indicate slower speed). A tomographic IVUS image 1010 shows the current frame, and an automatic label 1240 can be generated using image analysis with the label presets described with respect to the current frame indicator 1215, e.g., by the vasculature segment abbreviation. Bookmark thumbnails 1250 appear when the user presses the bookmark option and/or the label preset option. A direction indicator 1260 is also included, showing, e.g., the orientation or direction of movement of the transducer array. Anterior (A), posterior (P), medial (M), lateral (L), and/or other suitable direction labels can be used. The direction indicator can include a compass arrow that moves based on the direction of movement. Interesting anatomy 1270 (e.g., thrombus) within the IVUS image 1010 can be colored, shaded, and/or highlighted.” [0059-0062] as shown in Figs 4A-4E of Strommer_903), and colors the second element distinguishably from the first element ([0109] of CHAO “FIG. 23 is a screenshot of a pullback navigation and marking display 2200, in accordance with at least one embodiment of the present disclosure. Visible are the live tomographic IVUS image 1010, image longitudinal display (ILD) 1020, virtual venogram 500, pullback speed indicator 520, one-line user instruction 2210, labeling button 2220, artery 2230 (no longer bifurcating but now joined into a single lumen), and bifurcating vein 2240. In this example, the common iliac vein (CIV) 540 has been marked and highlighted on the virtual venogram, indicating that this is the segment of the patient's vasculature presently occupied by the ultrasound imaging array 124. In this example, the right external iliac vein (EIV) 550 is marked in a different color (e.g., light gray) to indicate this is the next segment the imaging array 124 will enter. The rest of the right-leg vasculature 1720 is marked with dotted lines, to show that it is not currently involved in the pullback procedure, while the left leg vasculature is grayed out (e.g., displayed with a gray color close to the background color) to indicate that it will not be involved in the pullback procedure at all.) In addition, the same motivation is used as the rejection for claim 1. CHAO and Strommer_903 are understood to be silent on the remaining limitations of claim 13.
In the same field of endeavor, Jiang teaches wherein the control unit is configured to define the first element and the second element in a three-dimensional image that is the image(see at least [0044-0045] as shown in Fig.2 of Jiang), the first element being defined as at least a voxel representing an inner surface of the biological tissue or a voxel adjacent to the voxel representing the inner surface and representing the lumen in a first voxel group corresponding to a position of the sensor, the second element being defined as at least a voxel representing the inner surface or a voxel adjacent to the voxel representing the inner surface and representing the lumen in a second voxel group corresponding to a position of the sensor at time of the user operation (see [0011] of Jiang “The volume graphic can for example be provided in the form of 3D image data. 3D image data is to be understood here as a dataset comprising data for individual volume elements (voxel-volume elements) of the imaged volume. For each volume element in this case an intensity value for a gray tone can be specified or a number of intensity values for a color tone of the volume graphic can be specified.”; [0044] The blood vessel 40 examined in the underlying example by means of an imaging system 10 is shown in FIG. 2. FIG. 2 shows the situation after the image data 36 and the position data 34 have been obtained by means of the catheter 12. The catheter 12 was moved along a course or a path or a track 42 through the blood vessel 40. At a number of different positions 44 along the track 42 image data 36 is created by means of the ultrasound unit 20 for a cross-section 46 of the vessel 40 by the ultrasound unit 20. In FIG. 2 the cross-sections 46 are illustrated in each case as the sectional set of the points which was produced between the plane in which the cross-section 46 was obtained and the blood vessel 40. In the image data of each cross-section 46 the blood present in the vessel 40 around the catheter 12, an internal surface 48 of the vessel 40, a vessel wall 50 of the vessel 40 itself and if necessary also a part of the body tissue surrounding the vessel wall 50 are visible”), and colors the second element distinguishably from the first element ([0011] of Jiang “The volume graphic can for example be provided in the form of 3D image data. 3D image data is to be understood here as a dataset comprising data for individual volume elements (voxel-volume elements) of the imaged volume. For each volume element in this case an intensity value for a gray tone can be specified or a number of intensity values for a color tone of the volume graphic can be specified.”)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of marking the location of an intravascular imaging probe during an IVUS pullback of CHAO and Strommer_903 with using individual volume elements (voxel-volume elements) of the imaged volume as seen in Jiang because this modification would achieve the expected benefits of providing accurate representation of internal volume.
Thus, the combination of CHAO , Strommer_903 and Jiang teaches wherein the control unit is configured to define the first element and the second element in a three-dimensional image, the first element being defined as at least a voxel representing an inner surface of the biological tissue or a voxel adjacent to the voxel representing the inner surface and representing the lumen in a first voxel group corresponding to a position of the sensor, the second element being defined as at least a voxel representing the inner surface or a voxel adjacent to the voxel representing the inner surface and representing the lumen in a second voxel group corresponding to a position of the sensor at time of the user operation, and colors the second element distinguishably from the first element.
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.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH LE whose telephone number is (571)270-7842. The examiner can normally be reached Monday: 8AM-4:30PM EST, Tuesday: 8 AM-3:30PM EST, Wednesday: 8AM-2:30PM EST, Thursday and Friday off.
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/SARAH LE/Primary Examiner, Art Unit 2614
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