Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/30/2025 has been entered. Claims 1, 3-21, and 23-25 remain pending in the application.
Response to Amendment
Claims 1, 3-21, and 23-25 remain pending in the application in response to the applicant’s amendments to the rejections previously set forth in the Final Office Action mailed 10/03/2025.
Response to Arguments
Applicant’s arguments filed 12/30/2025 with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over N. Hotta et al, "Usefulness of Real-Time 4D Ultrasonography during Radiofrequency Ablation in a Case of Hepatocellular Carcinoma", Case Reports in Gastroenterology, vol. 5, pp. 82-87, Feb. 2011 in view of W. Lee et al, "A 10-Fr Ultrasound Catheter With Integrated Micromotor for 4-D Intracardiac Echocardiography", IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, vol. 58, no. 7, pp. 1478-1491, July 2011, hereinafter referred to as Hotta and Lee, respectively.
Regarding claim 1, Hotta teaches a system for providing tissue analysis and visualization, the system comprising:
a console comprising a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor (see pg. 83, para. 4 - "We performed contrast-enhanced US with a PVT-382MV probe [imaging device] from APLIO XG (Toshiba Medical Systems, Otawa, Japan)." Where a console (Toshiba APLIO XG ultrasound imaging system) with a processor and a memory configured to perform instructions is known in the art) to cause the console to:
receive three-dimensional (3D)/four-dimensional (4D) ultrasound image data from an imaging device (see Abstract - "We report a case of hepatocellular carcinoma (HCC) with chronic hepatitis C virus infection successfully treated with percutaneous radiofrequency ablation (RFA) under live fourdimensional (4D) echo guidance."; see pg. 83, para. 4 - "We performed contrast-enhanced US with a PVT382MV probe [imaging device] from APLIO XG (Toshiba Medical Systems, Otawa, Japan). The vascularity of the HCC [hepatocellular carcinoma] lesion was assessed by microflow imaging using 0.5 ml of sonazoid (Daiichi-Sankyo, Tokyo, Japan) [7]. The US imaging was focused at the base of the target tumor."),
the 3D/4D image data comprising at least real-time 3D volumetric data being associated with an anatomical region of interest including a targeted tissue site and perfusion of a contrast agent therewith at least one of before, during, and after an ablation procedure being performed thereon (see pg. 83, para. 4-5 - "The vascularity of the HCC lesion was assessed by microflow imaging using 0.5 ml of sonazoid [perfusion of contrast agent] (Daiichi-Sankyo, Tokyo, Japan) [7]. The US imaging was focused at the base of the target tumor... RFA [radiofrequency ablation] was conducted for 12 min under a percutaneous approach using an expandable LeVeen needle with a hook 3.5 cm in diameter (Boston Scientific, USA). During and after the procedure, real-time 4D US was applied for accurate positioning of the needle and for confirmation of adequate ablation with a sufficient safety margin."); and
dynamically reconstruct multiple images from the 3D/4D image data to provide a real-time 3D visualization of the anatomical region of interest and targeted tissue site, based, at least in part, on analysis of perfusion of the contrast agent relative to vasculature associated at least with the targeted tissue site (Fig. 1-3, real time 3D images; see pg. 83, para. 2 - "Herein we report a case with HCC successfully treated with percutaneous RFA under real-time 4D US guidance."; see pg. 83, para. 4 - "The US imaging was focused at the base of the target tumor. The images were taken in the early vascular phase from 10 S until 40 S after injection; tumor vessel and staining were clearly observed (fig. 1).").
Hotta teaches receiving three-dimensional (3D)/four-dimensional (4D) ultrasound image data from an imaging device, but does not explicitly teach where the imaging device is an intravascular ultrasound (IVUS) imaging device or an intracardiac echocardiography (ICE) imaging device.
Whereas, Lee, in an analogous field of endeavor, teaches receiving three-dimensional (3D)/four-dimensional (4D) ultrasound image data from one of an intravascular ultrasound (IVUS) imaging device and an intracardiac echocardiography (ICE) imaging device (see Abstract – “We developed prototype real-time 3-D intracardiac echocardiography catheters with integrated micromotors… The 4-D ICE catheters were capable of imaging a 90° azimuth by up to 180° elevation field of view.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified receiving three-dimensional (3D)/four-dimensional (4D) ultrasound image data from an imaging device, as disclosed in Hotta, by having imaging device be an intracardiac echocardiography (ICE) imaging device, as disclosed in Lee. One of ordinary skill in the art would have been motivated to make this modification in order to provide a volumetric field of view, from which multiple orthogonal B-scans, C-scans, and rendered volumes can be displayed and electronically manipulated, easing the requirement for precisely positioning a single image plane, as taught in Lee (see pg. 1479, col. 1, para. 4).
Furthermore, regarding claim 3, Hotta further teaches wherein the 3D visualization comprises visualization of lesion formations in the targeted tissue site (see pg. 83, para. 4 - "RFA was conducted for 12 min under a percutaneous approach using an expandable LeVeen needle with a hook 3.5 cm in diameter (Boston Scientific, USA) [creates lesion formation]. During and after the procedure, real-time 4D US was applied for accurate positioning of the needle and for confirmation of adequate ablation with a sufficient safety margin.").
Furthermore, regarding claim 4, Hotta further teaches wherein the tissue comprises microvasculature associated with the targeted tissue site (see pg. 83, para. 4 - "The vascularity of the HCC lesion was assessed by microflow imaging using 0.5 ml of sonazoid [perfusion of contrast agent] (Daiichi-Sankyo, Tokyo, Japan) [7]. The US imaging was focused at the base of the target tumor.").
Furthermore, regarding claim 5, Hotta further teaches wherein the analysis comprises identifying perfusion characteristics in the microvasculature (see pg. 83, para. 4 - "The vascularity of the HCC lesion was assessed by microflow imaging using 0.5 ml of sonazoid [identifying perfusion characteristic in microvasculature] (Daiichi-Sankyo, Tokyo, Japan) [7]. The US imaging was focused at the base of the target tumor.").
Furthermore, regarding claim 6, Hotta further teaches wherein a lesion formation is identified based on the perfusion characteristics (see pg. 83, para. 4-5 - "The vascularity of the HCC lesion was assessed by microflow imaging using 0.5 ml of sonazoid [identifying perfusion characteristic in microvasculature] (Daiichi-Sankyo, Tokyo, Japan) [7]. The US imaging was focused at the base of the target tumor RFA was conducted for 12 min under a percutaneous approach using an expandable LeVeen needle with a hook 3.5 cm in diameter (Boston Scientific, USA) [creates lesion formation]. During and after the procedure, real-time 4D US was applied for accurate positioning of the needle and for confirmation of adequate ablation with a sufficient safety margin." Known in the art that formed ablation lesions at the tumor site stops blood flow in tumor site, so it is inherent that lesion formation is identified based on perfusion characteristics).
Furthermore, regarding claim 7, Hotta further teaches wherein the console is configured to correlate perfusion characteristics within a given location of the microvasculature with physical characteristics of the microvasculature at said given location (see pg. 83, para. 4-5 - "The vascularity of the HCC lesion was assessed by microflow imaging using 0.5 ml of sonazoid [identifying perfusion characteristic in microvasculature] (Daiichi-Sankyo, Tokyo, Japan) [7]. The US imaging was focused at the base of the target tumor RFA was conducted for 12 min under a percutaneous approach using an expandable LeVeen needle with a hook 3.5 cm in diameter (Boston Scientific, USA) [creates lesion formation]. During and after the procedure, real-time 4D US was applied for accurate positioning of the needle and for confirmation of adequate ablation with a sufficient safety margin." Known in the art that formed ablation lesions at the tumor site stops blood flow in tumor site, so it is inherent that lesion formation is identified based on perfusion characteristics).
Furthermore, regarding claim 8, Hotta further teaches wherein the perfusion characteristics comprise a plurality of gradations of propagation and accumulation of contrast agent into a given location of microvasculature (see pg. 83, para. 4-5 - "The vascularity of the HCC lesion was assessed by microflow imaging using 0.5 ml of sonazoid [identifying perfusion characteristic in microvasculature] (Daiichi-Sankyo, Tokyo, Japan) [7]. The US imaging was focused at the base of the target tumor RFA was conducted for 12 min under a percutaneous approach using an expandable LeVeen needle with a hook 3.5 cm in diameter (Boston Scientific, USA) [creates lesion formation]. During and after the procedure, real-time 4D US was applied for accurate positioning of the needle and for confirmation of adequate ablation with a sufficient safety margin." Known in the art that formed ablation lesions at the tumor site stops blood flow in tumor site, so it is inherent that lesion formation is identified based on perfusion characteristics).
Furthermore, regarding claim 9, Hotta further teaches wherein: unobstructed propagation and accumulation of contrast agent into a given location of microvasculature is indicative of unaffected and otherwise healthy microvasculature; and lack of propagation and accumulation of contrast agent into a given location is indicative of damaged microvasculature (see pg. 83, para. 4-5 - "The vascularity of the HCC lesion was assessed by microflow imaging using 0.5 ml of sonazoid [identifying perfusion characteristic in microvasculature] (Daiichi-Sankyo, Tokyo, Japan) [7]. The US imaging was focused at the base of the target tumor RFA was conducted for 12 min under a percutaneous approach using an expandable LeVeen needle with a hook 3.5 cm in diameter (Boston Scientific, USA) [creates lesion formation]. During and after the procedure, real-time 4D US was applied for accurate positioning of the needle and for confirmation of adequate ablation with a sufficient safety margin." Known in the art that formed ablation lesions at the tumor site stops blood flow in tumor site, so it is inherent that lesion formation is identified based on perfusion characteristics).
Furthermore, regarding claim 10, Hotta further teaches wherein the damaged microvasculature is a result of ablation and the lack of propagation and accumulation of contrast agent into the given location is indicative of a portion of a lesion formation (see pg. 83, para. 4-5 - "The vascularity of the HCC lesion was assessed by microflow imaging using 0.5 ml of sonazoid [identifying perfusion characteristic in microvasculature] (Daiichi-Sankyo, Tokyo, Japan) [7]. The US imaging was focused at the base of the target tumor RFA was conducted for 12 min under a percutaneous approach using an expandable LeVeen needle with a hook 3.5 cm in diameter (Boston Scientific, USA) [creates lesion formation]. During and after the procedure, real-time 4D US was applied for accurate positioning of the needle and for confirmation of adequate ablation with a sufficient safety margin." Known in the art that formed ablation lesions at the tumor site stops blood flow in tumor site, so it is inherent that lesion formation is identified based on perfusion characteristics).
Furthermore, regarding claim 11, Hotta further teaches wherein the console is configured to characterize a lesion formation based, at least in part, on correlation of the perfusion characteristics with physical characteristics of a given location of the microvasculature (see pg. 83, para. 4-5 - "The vascularity of the HCC lesion was assessed by microflow imaging using 0.5 ml of sonazoid [identifying perfusion characteristic in microvasculature] (Daiichi-Sankyo, Tokyo, Japan) [7]. The US imaging was focused at the base of the target tumor...RFA was conducted for 12 min under a percutaneous approach using an expandable LeVeen needle with a hook 3.5 cm in diameter (Boston Scientific, USA) [creates lesion formation]. During and after the procedure, real-time 4D US was applied for accurate positioning of the needle and for confirmation of adequate ablation with a sufficient safety margin." Known in the art that formed ablation lesions at the tumor site stops blood flow in tumor site, so it is inherent that lesion formation is identified based on perfusion characteristics).
Furthermore, regarding claim 12, Hotta further teaches wherein the physical characteristics are one or more of flow, microflow, and stiffness (see pg. 83, para. 4 - "The vascularity of the HCC lesion was assessed by microflow imaging using 0.5 ml of sonazoid (Daiichi-Sankyo, Tokyo, Japan) [7]. The US imaging was focused at the base of the target tumor.").
Furthermore, regarding claim 13, Hotta further teaches wherein characterization comprises providing a visual indication of at least one of an extent of the lesion formation, transmurality of the lesion formation, and continuity of an ablation path associated with the lesion formation (see pg. 83, para. 4-5 - "The vascularity of the HCC lesion was assessed by microflow imaging using 0.5 ml of sonazoid [identifying perfusion characteristic in microvasculature] (Daiichi-Sankyo, Tokyo, Japan) [7]. The US imaging was focused at the base of the target tumor RFA was conducted for 12 min under a percutaneous approach using an expandable LeVeen needle with a hook 3.5 cm in diameter (Boston Scientific, USA). During and after the procedure, real-time 4D US was applied for accurate positioning of the needle and for confirmation of adequate ablation with a sufficient safety margin.").
Furthermore, regarding claim 20, Hotta further teaches wherein the contrast agent is injected into vasculature at least one of before and after performing one or more ablation procedures (see pg. 83, para. 4-5 - "The vascularity of the HCC lesion was assessed by microflow imaging using 0.5 ml of sonazoid [perfusion of contrast agent] (Daiichi-Sankyo, Tokyo, Japan) [7]. The US imaging was focused at the base of the target tumor RFA [radiofrequency ablation] was conducted for 12 min under a percutaneous approach using an expandable LeVeen needle with a hook 3.5 cm in diameter (Boston Scientific, USA). During and after the procedure, real-time 4D US was applied for accurate positioning of the needle and for confirmation of adequate ablation with a sufficient safety margin.").
Claims 14-19, 21, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Hotta in view of Lee, as applied to claim 11 above, and in further view of Panescu (US 20030208123 A1, published November 6, 2003), from IDS, hereinafter referred to as Panescu.
Regarding claim 14, Hotta in view of Lee teaches all of the elements disclosed in claim 11 above.
Hotta in view of Lee teaches lesion formation in image data, but does not explicitly teach segmenting lesion formation into at least three different regions.
Whereas, Panescu, in the same field of endeavor, teaches wherein the console is configured to segment a given lesion formation into at least three different regions comprising a core region, a border region immediately adjacent to and surrounding the core region, and a periphery region immediately adjacent to and surrounding the border region (Fig. 7; see para. 0037 - "The ultrasound image shows a cross-section of a heart chamber containing the ablation lesion 630. In the ultrasound image, the ablation lesion 630 appears as a dark region [core region], while the live tissue 625 in the heart chamber wall 740 surrounding the ablation lesion 630 appears as a white region [periphery region] due to the presence of echogenic particles in the live tissue 625." Where a "border region" between the lesion (core region) and live tissue (periphery region) is inherent).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified lesion formation, as disclosed in Hotta in view of Lee, by segmenting lesion formation into at least three different regions, as disclosed in Panescu. One of ordinary skill in the art would have been motivated to make this modification in order to further provide a physician with valuable feedback on the extent and/or depth of an ablation lesion during an ablation procedure, as taught in Panescu (see para. 0038).
Furthermore, regarding claim 15, Panescu further teaches wherein a core region of a lesion formation is associated with a complete, or near complete, lack of propagation and accumulation of contrast agent into a given location of the microvasculature and appears normal within a 3D ultrasound image (see para. 0029 - "The tissue in the ablation lesion is characterized by necrosis (i.e., dead tissue). In addition, the capillaries in the ablation lesion are closed, stopping blood flow to the tissue in the ablation lesion." It is inherent that a lesion itself has no flow (lack of propagation, and accumulation of contrast agent)).
Furthermore, regarding claim 16, Panescu further teaches wherein a border region of a lesion formation is associated with some propagation and accumulation of contrast agent into a given location of the microvasculature and presents a stronger backscatter signal within a 3D ultrasound image as compared to a backscatter signal associated with the core region (see para. 0029 - "The tissue in ablation lesion is characterized by necrosis (i.e., dead tissue). In addition, the capillaries in the ablation lesion are closed, stopping blood flow to the tissue in the ablation lesion." It is inherent that the area around a lesion has some flow ("some" propagation and accumulation of contrast agent)).
Furthermore, regarding claim 17, Panescu further teaches wherein a periphery region of a lesion formation is associated with substantially unobstructed propagation and lack of accumulation of contrast agent into a given location of microvasculature and presents a weaker backscatter signal within a 3D ultrasound image as compared to backscatter signals associated with the border region a short time after injection (see para. 0029 - "The tissue in the ablation lesion is characterized by necrosis (i.e., dead tissue). In addition, the capillaries in the ablation lesion are closed, stopping blood flow to the tissue in the ablation lesion." It is inherent that the area upstream of a lesion has normal flow (unobstructed propagation and lack of accumulation of contrast agent)).
Furthermore, regarding claim 18, Panescu further teaches wherein the console performs segmentation of a given lesion formation based, at least in part, on a segmentation algorithm (Fig. 7; see para. 0037 - "The ultrasound image shows a cross-section of a heart chamber containing the ablation lesion 630. In the ultrasound image, the ablation lesion 630 appears as a dark region, while the live tissue 625 in the heart chamber wall 740 surrounding the ablation lesion 630 appears as a white region due to the presence of echogenic particles in the live tissue 625." Where segmenting a lesion in an image based on a segmentation algorithm is known in the art).
Furthermore, regarding claim 19, Panescu further teaches wherein the segmentation algorithm comprises at least one of automatic thresholding, connected component analysis, and neural networkbased segmentation (Fig. 7; see para. 0037 - "The ultrasound image shows a cross-section of a heart chamber containing the ablation lesion 630. In the ultrasound image, the ablation lesion 630 appears as a dark region, while the live tissue 625 in the heart chamber wall 740 surrounding the ablation lesion 630 appears as a white region due to the presence of echogenic particles in the live tissue 625." Where segmenting a lesion in an image based on a segmentation algorithm, including thresholding and neural network-based segmentation, is known in the art).
Furthermore, regarding claim 21, Panescu further teaches a catheter-based ultrasound imaging device operably coupled to the console and configured to transmit ultrasound pulses to, and receive echoes of the ultrasound pulses from at least one of intravascular and intracardiac tissue (see para. 0041 - "FIG. 8 illustrates an embodiment, in which the ultrasound image in step 540 is taken from within the heart chamber 810 by positioning an ultrasound imaging catheter 20 within the heart chamber 810.").
Furthermore, regarding claim 23, Panescu further teaches wherein the console is configured to receive at least full circumferential, 3D image data from the ultrasound imaging device in real, or near- real time, and the console is configured to reconstruct multiple images in real, or near-real time, based, at least in part, on at least one of user input and predefined protocols (see para. 0025 - "The local imaging subsystem 35 may continuously update the ultrasound image to provide a real-time image of the body."; see para. 0026 - "To obtain a three-dimensional image of a body volume, the ultrasound transducer 25 may be displaced axially within the catheter body 415 by, e.g., pulling back the drive shaft 430. As thetransducer25is displaced axially, the ultrasound transducer25is rotated [full circumferential] to obtain multiple cross-sectional images (i.e., "slices") of the body at different positions within the body. The ultrasound image processor 330 then aggregates (i.e., pieces together) the multiple cross-sectional images to reconstruct the volume of the body using known volume reconstruction methods [predefined protocols].").
Furthermore, regarding claim 24, Panescu further teaches wherein the console is configured to provide a 3D visualization of the anatomical region of interest and targeted tissue site during an ablation procedure being performed on the targeted tissue site (see para. 0023 - "A three-dimensional ultrasound image may be obtained from an ultrasound imaging device 20..."; see para. 0038 - "The ablation visualization method may be used to provide a physician with valuable feedback on the extent and/or depth of an ablation lesion during an ablation procedure. For example, the physician may create an ablation lesion at a targeted site, and use the ablation visualization method to measure the extent and/or depth of the ablation lesion.").
Furthermore, regarding claim 25, Panescu further teaches wherein the anatomical region of interest and targeted tissue site are associated with myocardial tissue (see para. 0040 - "In this case, a physician may still be able to ascertain the extent and/or depth of the ablation lesion [targeted tissue site] in the myocardium [myocardial tissue] by visualizing the underlying non-charred tissue of the ablation lesion." Where the anatomical ROI is the heart).
The motivation for claims 15-19, 21, and 23-25 was shown previously in claim 14.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Hope Simpson et al. (US 20210353251 A1, published November 18, 2021) discloses where the ultrasound probe may be in any suitable form for imaging various body parts of a patient while positioned inside or outside of the patient's body, such as an intraluminal device, an intravascular ultrasound (IVUS) catheter, or an intracardiac echocardiography (ICE) catheter.
Webler et al. (US 20070167801 A1, published July 19, 2007) discloses where the ultrasonic imaging device is typically an external device, a TTE probe, an ICE probe (Intracardiac Echo, probe in a cardiac chamber), or an IVUS (Intravascular Ultrasound, probe in a vessel), and the ultrasonic imaging device perform 4D ultrasound imaging.
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/Nyrobi Celestine/Examiner, Art Unit 3798