DETAILED ACTION
This action is in response to the application filed on September 26, 2024. Claims 1-20 are pending and have been examined.
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 .
Priority
Receipt is acknowledged that application claims priority to foreign application with application number JP2022/061024 dated March 31, 2022. Copies of certified papers required by 37 CFR 1.55 have been received. Priority is acknowledged under 35 USC 119(e) and 37 CFR 1.78.
Receipt is acknowledged that application is a National Stage application of PCT PCT/JP2023/008441 with a priority date of March 07, 2023 is acknowledged under 35 USC 119(e) and 37 CFR 1.78.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on September 26, 2024 and August 13, 2025 are being considered by the examiner.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 12, 15, and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moore’117 et al, US 20190082117 in view of Olivan et al, US 20170095296 in view of Sakaguchi’960 et al, WO 2021199960.
Regarding claim 1, Moore’117 teaches
An imaging apparatus for medical diagnosis, comprising (see Moore’117, Paragraph [0002], “Intravascular imaging is often used to identify diagnostically significant characteristics of a vessel. For example, an intravascular imaging system may be used by a healthcare professional to help identify and locate blockages or lesions in a vessel,” and Paragraph [0027], “FIG. 1 illustrates an intravascular imaging system 100, according to an example embodiment”):
a catheter insertable into a vessel (see Moore’117, Paragraph [0027], “The catheter assembly 102 may include a proximal end 104 and a distal end 106 configured to be inserted into a vessel of a patient 118”)
and including a scanner rotatable therein (see Moore’117, Paragraph [0044], “the catheter 200 may be a mechanically rotating ultrasound imaging catheter similar to catheters previously described (e.g., catheter assembly 102). Likewise, the catheter 200 may be configured to rotate an ultrasound transducer (not shown) relative to a sheath of the catheter 200,”),
wherein the catheter is configured to acquire images of the vessel from signals emitted from and received by the scanner (see Moore’117, Paragraph [0028], “catheter assembly 102 may include a transducer 108 within distal end 106 configured to emit and receive wave-based energy and generate imaging data—e.g., to image the area of interest within the patient 118”);
and a processor configured to (see Moore’117, Paragraph [0084], “Processes herein described may be encoded in non-transitory computer-readable medium containing executable instructions for causing a processor to carry out such processes”):
control the catheter to emit the signals along scanning lines (see Moore’117, Paragraph [0044], “The ultrasound data vectors illustrated in FIG. 4 are indicative of acoustic energy emitted and received by the ultrasound transducer at different rotational positions”)
and acquire the images of the vessel from the signals received by the scanner, for each of the acquired images (see Moore’117, Fig.2A, Paragraph [0045], “ultrasound transducer may initially acquire an ultrasound data vector 202A and continue to acquire vectors 202B through 202n as the ultrasound transducer is rotated clockwise. Accordingly, vectors 202A-202n can be representative of a full 360-degree rotation of the ultrasound transducer within a vessel and make up a single frame,” and Paragraph [0047], “data frame 204 can include imaging data at a cross-section of the vessel 202 within an imaging view 206 that is defined by the particular imaging parameters used in a specific application”),
determine a representative line based on brightness values of pixels of the image, and for each of the scanning lines of the image (see Moore’117, Paragraph [0053], “FIG. 5A illustrates a set of brightness data arranged for display, according to an example embodiment. In this example, brightness data is arranged in polar coordinates, with data points 440-448 divided both angularly and radially. Each angular section separated by bold lines represents a vector of brightness data, corresponding to an orientation of the transducer 108 during image information acquisition. Each point within an angular section represents a data point within that vector”),
determine a calculation range based on an intersection of the representative line and the scanning line (see Moore’117, Paragraph [0057], “Another example of spatial filtering can comprise averaging all data points within a certain spatial distance of a certain point and within the same vector as the certain point—a technique called radial averaging. For example, points 440, 441, and 442 can be averaged along line 460 to generate spatially filtered data at 441. Yet another spatial filtering example can comprise averaging all data points within a certain distance of a certain point and having the same radial position within their corresponding vector—a technique called angular averaging. For example, points 441, 444, and 447 can be averaged along line 450 to generate spatially filtered data at 444”),
and calculate an index value using brightness values of pixels of the scanning line, the pixels being located in the calculation range, (see Moore’117, Fig. 5A, 450 and 460 are considered to be index values of pixels of the scanning line),
and generate a two-dimensional image in which pixels corresponding to the scanning lines of each image (see Moore’117, Fig. 6, 626 generate image based on filtered image information, and Paragraph [0073], “the intravascular imaging engine can include an image generator configured to generate an image representing the image information received from the transducer 626”).
Moore’117 does not expressively teach
determine colors corresponding to the index values calculated for the scanning lines of each image,
However, Olivan in a similar invention in the same field of endeavor teaches
determine colors corresponding to the index values calculated for the scanning lines of each image (see Olivan, Paragraph [0049], “The projection unit 14 is further adapted to provide assignments between projection values and visualization properties. The visualization properties define preferentially degrees of opacity and/or colors and/or brightness”),
The combination of Moore’117 and Olivan are analogous art because they are both in the same field of endeavor of intravascular imaging with a catheter. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to provide assignments between projection values and visualization properties such as colors; for pixels on the display located in the neighborhood of the intersection point C to be colored accordingly as taught in the apparatus of Olivan in the system of Moore’117 to allow the user to easily and accurately grasp the three-dimensional spatial relationship between the first object and the second object, first object being the catheter and second object being a vascular structure (Olivan, Abstract).
Moore’117 in view of Olivan does not expressively teach
and having the determined colors are arranged in a first direction that crosses a second direction corresponding to a longitudinal direction of the vessel.
However, Sakaguchi’960 in a similar invention in the same field of endeavor teaches
and having the determined colors are arranged in a first direction that crosses a second direction corresponding to a longitudinal direction of the vessel (see Sakaguchi’960, Paragraph [0046] “In this case, the control unit 21 can display the area to be treated by, for example, surrounding it with a frame or coloring it. The user can observe the changes in the state of the tubular organ along its longitudinal direction using the schematic diagram in section 524”).
The combination of Moore’117, Olivan, and Sakaguchi’960 are analogous art because they are all in the same field of endeavor of intravascular imaging with a catheter. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to display the area by coloring it and observe the changes along the longitudinal direction as taught in the system of Sakaguchi’960 in the system of Moore’117 in view of Olivan to aid diagnosis or treatment (Sakaguchi’960, Abstract).
Regarding claim 2, Moore’117 in view of Olivan in view of Sakaguchi’960 further teaches the imaging apparatus according to claim 1,
wherein the representative line in each acquired image is a closed curve surrounding the catheter (see Moore’117, Figs. 2A & 2B, see Paragraph [0047], “For instance, variations in ultrasound backscatter levels along a data vector may be used to determine the boundary between the vessel lumen 226 and the vessel wall 224. For example, vessel wall 224 and the fluid within vessel lumen 226 (e.g., blood or blood-displacement fluid) may reflect varying amounts of acoustic energy emitted by the ultrasound transducer of catheter 200,” catheter 200 is surrounded by a closed curve 224 which is the vessel wall and is considered to be a representative line).
The rationale of claim 1 has been applied herein.
Regarding claim 3, Moore’117 in view of Olivan in view of Sakaguchi’960 further teaches the imaging apparatus according to claim 1,
wherein the representative line in each acquired image has a circular shape surrounding the catheter (see Moore’117, Figs. 2A & 2B, , see Paragraph [0047], “For instance, variations in ultrasound backscatter levels along a data vector may be used to determine the boundary between the vessel lumen 226 and the vessel wall 224. For example, vessel wall 224 and the fluid within vessel lumen 226 (e.g., blood or blood-displacement fluid) may reflect varying amounts of acoustic energy emitted by the ultrasound transducer of catheter 200,” catheter 200 is surrounded by a circular shape 224 which is the vessel wall and is considered to be a representative line).
The rationale of claim 1 has been applied herein.
Regarding claim 12, Moore’117 in view of Olivan in view of Sakaguchi’960 further teaches the imaging apparatus according to claim 1,
wherein the processor determines the calculation range to include pixels corresponding to the intersections of the representative line and each scanning line (see Olivan, Paragraph [0062], “If C is the intersection point between the line (P, V) and the inner surface of the vascular structure, for each point PS on the inner surface of the vascular structure in a neighborhood of C a distance can be defined like the three-dimensional Euclidean distance between P and PS or like the distance of the minimum length path between C and PS over the inner surface of the vascular structure. … The pixels on the display at the positions where the surface positions are located in the neighborhood of the intersection point C are colored accordingly and optionally blended with a background image, which might be, for instance, a live fluoroscopy image and/or an image showing the pre-interventional three-dimensional representation of the vascular structure”).
The rationale of claim 1 has been applied herein.
Regarding claim 15, Moore’117 in view of Olivan in view of Sakaguchi’960 further teaches the imaging apparatus according to claim 1, further comprising:
a display, wherein the processor is configured to control the display to display the two-dimensional image (see Moore’117, Paragraph [0032], “the user interface 120 may include the display 114, which may be configured to display system information and/or imaging signals from the catheter assembly 102 (e.g., intravascular images)”).
The rationale of claim 1 has been applied herein.
As per claim 17, Claim 17 claims a method for medical diagnosis, the method comprising the same limitations as Claim 1. Therefore, the rejection and rationale are analogous to that made in Claim 1.
As per claim 18, Claim 18 claims the same limitations as Claim 2 and is dependent on a similarly rejected independent claim. Therefore, the rejection and rationale is analogous to that made in Claim 2.
As per claim 19, Claim 19 claims the same limitations as Claim 3 and is dependent on a similarly rejected independent claim. Therefore, the rejection and rationale is analogous to that made in Claim 3.
As per claim 20, Claim 20 claims a non-transitory computer readable storage medium storing a program causing a computer to execute a method for medical diagnosis, the method comprising the same limitations as Claim 1. Therefore, the rejection and rationale are analogous to that made in Claim 1.
Moore’117 further teaches a non-transitory computer readable storage medium storing a program causing a computer to execute a method for medical diagnosis (see Moore’117, Paragraph [0084], “Non-transitory computer-readable medium can be included in memory in the intravascular imaging engine 112”).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moore’117 et al, US 20190082117 in view of Olivan et al, US 20170095296 in view of Sakaguchi’960 et al, WO 2021199960 in view of Sakaguchi’569 et al, US 20180042569.
Regarding claim 6, Moore’117 in view of Olivan in view of Sakaguchi’960 does not expressively teach the imaging apparatus according to claim 1,
wherein the processor calculates the index value based on one or more of a first index value, a second index value, and a third index value, each of which is calculated by a different calculation method.
However, Sakaguchi’569 in a similar invention in the same field of endeavor teaches
wherein the processor calculates the index value based on one or more of a first index value, a second index value, and a third index value, each of which is calculated by a different calculation method (see Sakaguchi’569, Paragraph [0034], “the medical-information processing apparatus 300 calculates an index value that represents the proportional relationship between the flow volume and the pressure within a blood vessel with more accuracy and an index value that corresponds to the instantaneous FFR that is invasively measured by using a catheter,” given the broadest reasonable interpretation- one or more of a first index value is considered to be one index value that is calculated).
The combination of Moore’117, Olivan, Sakaguchi’960, and Sakaguchi’569 are analogous art because they are all in the same field of endeavor of intravascular imaging with a catheter. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to calculate an index value that represents a proportional relationship between flow volume and the pressure within a blood vessel as taught in the system of Sakaguchi’569 in the system of Moore’117 in view of Olivan in view of Sakaguchi’960 to improve the accuracy of diagnosis with regard to blood flow (Sakaguchi’569, Abstract).
Allowable Subject Matter
Claim(s) 4-5, 7-11, 13-14, and 16 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIQUE JAMES whose telephone number is (703)756-1655. The examiner can normally be reached 9:00 am - 6:00 pm EST.
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/DOMINIQUE JAMES/Examiner, Art Unit 2666
/EMILY C TERRELL/Supervisory Patent Examiner, Art Unit 2666
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