DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 14, 17, 19, 22-25, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Vaidya et (JP2020506749, the US2021/0353362 is used for examination purposes) in the view of Errico et al (NPL: “Ultrafast ultrasound localization microscopy for deep super-resolution vascular imaging”).
Regarding claim 14, Vaidya teaches a device tracking system configured to generate a 3D anatomical image, monitor a target body structure of a patient, and localizing a device inside said target body structure, the tracking system comprising (figures 1 and 3, paras. 0023 and 0030; an exemplary system 100 of the invention for imaging and tracking an interventional tool 112 as it is directed to a region of interest 114 within a subject or patient 108. A volume renderer 834 may generate an image of the 3D dataset as viewed from a given reference point):
a control unit with a memory configured to store at least one ultrasound image of the target body structure, the control unit being configured to launch an acquisition of the least one ultrasound image, the control unit being an information emission/reception system configured to transform electric impulses into acoustic impulses (and vice versa) in order to enable an acoustic characterization of the target body structure (paras. 0029 and 0032; The transmission of ultrasonic pulses from transducers of the imaging elements 120, 122 may be directed by the transmit controller 820 coupled to the T/R switch 818 and the beamformer 822, which may receive input from the user's operation of a user interface 824. Output (e.g., images) from the scan converter 830, the multiplanar reformatter 832, and/or the volume renderer 834 may be coupled to an image processor 836 for further enhancement, buffering and temporary storage before being displayed on an image display 838. In certain embodiments, the image processor 836 is configured to register images from the processed signal data. The examiner notes that the system comprises a controller unit that comprise multiple elements responsible for controlling the ultrasound image acquisition by a transmit controller and stores acquired images in a memory before displaying them),
a device comprising (figures 1 and 3, element 112, paras. 0021 and 0038-0040):
at least one steering element configured to be handled outside the target body structure (figures 1 and 3, element 112, paras. 0021 and 0038-0040; a physician inserts a device or tool into a patient's body to, e.g., biopsy, monitor, diagnose or treat. Typical interventional tools include, for example, guidewires, guide catheters or sheaths, delivery catheters, ablation catheters, imaging catheters, catheter sheaths, needles, and implantable devices (sensors, stents, filters, etc.). The examiner notes that the device is a catheter that is known to comprise a handle for the user to hold for insertion and manipulation of the catheter.), and
at least one steerable element measuring between 0.5mm and 3mm in diameter, configured to be introduced inside the target body structure and to be handled manually by means of the steering element, the steerable element and the steering element being physically connected by at least one connection element (paras. 0021-0022 and 0038-0040; the interventional device is configured for entry into one or more body lumens, and are imaged by the imaging elements. Various biological lumens include blood vessels, vasculature of the lymphatic and nervous systems, various structures of the gastrointestinal tract including lumen of the small intestine, large intestine, stomach, esophagus, colon, pancreatic duct, bile duct, hepatic duct, lumen of the reproductive tract including the vas deferens, vagina, uterus and fallopian tubes, structures of the urinary tract including urinary collecting ducts, renal tubules, ureter, and bladder, and structures of the head, neck and pulmonary system including sinuses, parotid, trachea, bronchi, and lungs. a preferred location of the sensor is at or proximate to a distal end of the interventional device. The examiner notes that the catheter is known to have a handle and a tip, where the tip diameter is selected based on the interventional procedure. Vascular catheters are known to have a small diameter to enter the vessel and are conventionally sized within 0.5-3 mm outer diameter. Therefore, the claimed diameter is inherent.),
at least one probe configured to be brought in contact with a securing body part of the patient, the securing body part surrounding at least partially the target body structure, the at least one probe being configured to be in real time communication with the control unit, and the at least one probe being configured to be removably secured to the securing body part of the patient (figure 1, elements 120 and 122, para. 0023; The system 100 includes at least two imaging elements 122, 120. In some instances, systems of the invention include 2, 3, 4, 5, or more imaging elements, the imaging elements may be fixed or immobile with respect to each other or a reference point. In other embodiments, at least one of the probes may be held immobile with respect to the region of interest. FIG. 2 shows imaging probe 106 in a fixed-stand 130. As an alternative to the fixed-stand 130, at least one of the imaging elements may be held against the subject using an adhesive patch or a band. The imaging elements 122, 120 are coupled to wires 124, which connect the imaging elements 122, 120 to one or more processors of an imaging system (described hereinafter). The imaging elements 122, 120 are positioned on a patient 108 in order to image a region of interest 114 and such that the field of view of each imaging element differs from each other. The examiner notes that the ultrasound probes are secured to the target structure using a band that is at least partially surrounding the target body structure.), and
at least one tracker configured to be secured to the steerable element of the device, the at least one tracker comprising an object strongly reflecting ultrasounds waves (paras. 0040 and 0042; the positional sensor 110 of the interventional tool 112 is configured to receive signals transmitted from the imaging elements 120, 122. For example, the imaging elements 120, 122 transmit imaging signals as described above, and the positional sensor 110 passively listens to the signals transmitted from the imaging elements 120, 122. The received signals from the imaging elements 122, 120 by the positional sensor 110 can be used to determine the position of the positional sensor 110, and thus the position of the interventional tool 112 within the generated image. In addition to technique described above and shown in FIG. 5, it is also contemplated that the location of the positional sensor is tracked based on signals emitted from the positional sensor 110 and received by the two or more imaging elements 120, 122. The examiner notes that the position sensors fixed to the distal end of the catheter are ultrasound sensors/transducers),
wherein the at least one probe and the at least one tracker are configured to communicate by means of ultrasounds, the control unit being thus configured to localize, in real time, the steerable element inside the target body structure (para. 0041; he positional sensor 110 is configured to receive signals from imaging element 122. The positional sensor 110 and the imaging element 122 are connected to and in communication with an imaging system (e.g. the same processing system or separate processing systems in communication with each other). In order to determine the position of the positional sensor 110 (and thus the interventional tool 112), the imaging element 122 sends and receives signals to generate an image of a region of interest. When the signals are transmitted for imaging, a trigger is sent to the imaging system and/or the positional sensor 110 that indicates when the signal was sent (e.g. starts the clock for a particular signal at zero). The transmitted signal is then received by the positional sensor 110, and time delay between when the signal was transmitted and when the signal was received (e.g. the time of flight of the signal) is used to determine the position of the positional sensor 110 within the imaging beam. That is, the time from beam emission to reception by the positional sensor indicates the depth of the positional sensor 110 within the imaging beam. This can be repeated for a plurality of imaging signals for real-time tracking of the positional sensor and thus the interventional tool in images.), and
wherein the control unit is configured to localize the steerable element by means of ultrasound localization (para. 0041; This can be repeated for a plurality of imaging signals for real-time tracking of the positional sensor and thus the interventional tool in images.),
wherein the control unit is further configured to display, on a screen, the at least one stored ultrasound image and display, in real time, the localization of the steerable element on said at least one stored ULM ultrasound image (paras. 0032 and 0044; Ideally, the techniques are continuously repeated by one or more imaging elements 120, 122 to provide real-time tracking of the positional sensor 110 within the registered images generated by the imaging elements 120, 122. With the location of the positional sensor 110 determined by at least one of the imaging elements 120, 122, its location can be registered to the fused image generated from the imaging elements 120, 120. For example, the location of the positional sensor 110 can be overlaid in the registered image from the imaging elements for enhanced visualization of the interventional tool 112. A graphical element is used to show the positional sensor 110 in the resulting image on the monitor. ] Output (e.g., images) from the scan converter 830, the multiplanar reformatter 832, and/or the volume renderer 834 may be coupled to an image processor 836 for further enhancement, buffering and temporary storage before being displayed on an image display 838. In certain embodiments, the image processor 836 is configured to register images from the processed signal data. The examiner notes that the images received from the probes are stored and registered before overlaying real time position information of the catheter), and
wherein the control unit is configured to combine the real time ultrasound information obtained from each probe regarding the at least one tracker and information of the stored ultrasound image (paras. 0032 and 0044; Ideally, the techniques are continuously repeated by one or more imaging elements 120, 122 to provide real-time tracking of the positional sensor 110 within the registered images generated by the imaging elements 120, 122. With the location of the positional sensor 110 determined by at least one of the imaging elements 120, 122, its location can be registered to the fused image generated from the imaging elements 120, 120. For example, the location of the positional sensor 110 can be overlaid in the registered image from the imaging elements for enhanced visualization of the interventional tool 112. A graphical element is used to show the positional sensor 110 in the resulting image on the monitor. ] Output (e.g., images) from the scan converter 830, the multiplanar reformatter 832, and/or the volume renderer 834 may be coupled to an image processor 836 for further enhancement, buffering and temporary storage before being displayed on an image display 838. In certain embodiments, the image processor 836 is configured to register images from the processed signal data. The examiner notes that the images received from the probes are stored and registered before overlaying real time position information of the catheter).
However, Vaidya fails to disclose that the ultrasound images are ULM images for generating 3D anatomical mapping.
Errico, in the same field of endeavor, teaches ULM image (figure 2, pages 499-500; we demonstrate ultrafast ultrasound localization microscopy (uULM), which combines deep penetration and super-resolution imaging at unprecedented spatiotemporal resolution, by using clinically approved contrast agents: inert gas microbubbles. we were able to track each moving bubble according to its instantaneous position and in-plane velocity vector, leading to quantitative and localized maps of cerebral blood flow velocity. Hence, ultrafast imaging allows the reconstruction of entire organs within tens of seconds, a prerequisite for a preclinical and clinical modality.).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the at least one ultrasound image of Vaidya to incorporate the ULM ultrasound image of Errico. This modification will allow detailed reconstruction of entire organs within tens of seconds and allow small objects to be detected with high accuracy as disclosed within Errico in page 500.
Regarding claim 17, Vaidya teaches the system according to claim 14, wherein the at least one probe comprises at least one ultrasound transducer and the at least one tracker comprises at least one ultrasound sensor (paras. 0026 and 0040; The imaging elements 120, 120 may include one or more ultrasound transducers. The ultrasound transducer may include piezoelectric transducer elements, capacitive micro-machined transducer elements, or any other suitable ultrasound transducer element. According to certain aspects, the positional sensor 110 of the interventional tool 112 is configured to receive signals transmitted from the imaging elements 120, 122. For example, the imaging elements 120, 122 transmit imaging signals as described above, and the positional sensor 110 passively listens to the signals transmitted from the imaging elements 120, 122. The received signals from the imaging elements 122, 120 by the positional sensor 110 can be used to determine the position of the positional sensor 110, and thus the position of the interventional tool 112 within the generated image.).
Regarding claim 19, Vaidya teaches the system according to claim 14, wherein the at least one tracker comprises at least one ultrasound transducer and the at least one probe comprises at least one ultrasound sensor (paras. 0026 and 0042; The imaging elements 120, 120 may include one or more ultrasound transducers. The ultrasound transducer may include piezoelectric transducer elements, capacitive micro-machined transducer elements, or any other suitable ultrasound transducer element. In addition to technique described above and shown in FIG. 5, it is also contemplated that the location of the positional sensor is tracked based on signals emitted from the positional sensor 110 and received by the two or more imaging elements 120, 122.).
Regarding claim 22, Vaidya teaches the system according to claim 14, wherein the device is a catheter, the at least one steerable element is a catheter tip, and the at least one steering element is a catheter handle (figure 1, paras. 0021 and 0038-0040; a physician inserts a device or tool into a patient's body to, e.g., biopsy, monitor, diagnose or treat. Typical interventional tools include, for example, guidewires, guide catheters or sheaths, delivery catheters, ablation catheters, imaging catheters, catheter sheaths, needles, and implantable devices (sensors, stents, filters, etc.). The examiner notes that the device is a catheter that is known to comprise a handle for the user to hold for insertion and manipulation of the catheter distal tip.).
Regarding claim 23, Vaidya teaches the system according to claim 14, wherein the memory of the control unit is configured to store a succession of ultrasound image of the target body structure, each new ultrasound image replacing a prior ultrasound image (paras. 0024, 0029, and 0032; The at least two imaging elements 120, 122 are configured to send imaging signals to and receive imaging signals from the region of interest within their respective field of views or a portion thereof. In certain embodiments, the imaging signals includes acoustic signals. In other embodiments, the imaging signals may be or also include photoacoustic signals. The received imaging signals of the region of interest can be used to generate one or more images. In certain embodiments, the received imaging signals generate a continuous imaging stream of the region of interest in real-time. Output (e.g., images) from the scan converter 830, the multiplanar reformatter 832, and/or the volume renderer 834 may be coupled to an image processor 836 for further enhancement, buffering and temporary storage before being displayed on an image display 838. The examiner notes that the imaging is a real time continuous imaging and the processor receives images and store them in real time before displaying them and continue to acquire new images.).
However, Vaidya fails to disclose that the ultrasound images are ULM images.
Errico, in the same field of endeavor, teaches ULM image (figure 2, pages 499-500; we demonstrate ultrafast ultrasound localization microscopy (uULM), which combines deep penetration and super-resolution imaging at unprecedented spatiotemporal resolution, by using clinically approved contrast agents: inert gas microbubbles. we were able to track each moving bubble according to its instantaneous position and in-plane velocity vector, leading to quantitative and localized maps of cerebral blood flow velocity. Hence, ultrafast imaging allows the reconstruction of entire organs within tens of seconds, a prerequisite for a preclinical and clinical modality.).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the at least one ultrasound image of Vaidya to incorporate the ULM ultrasound image of Errico. This modification will allow detailed reconstruction of entire organs within tens of seconds and allow small objects to be detected with high accuracy as disclosed within Errico in page 500.
Regarding claim 24, Vaidya teaches the according to claim 23, wherein the ultrasound image acquisition is done in real time, a new ultrasound image acquisition being launched as soon a prior ultrasound image acquisition is terminated, each new ultrasound image replacing the prior ultrasound image as soon its acquisition is terminated (paras. 0024 and 0032; The at least two imaging elements 120, 122 are configured to send imaging signals to and receive imaging signals from the region of interest within their respective field of views or a portion thereof. In certain embodiments, the imaging signals includes acoustic signals. In other embodiments, the imaging signals may be or also include photoacoustic signals. The received imaging signals of the region of interest can be used to generate one or more images. In certain embodiments, the received imaging signals generate a continuous imaging stream of the region of interest in real-time. Output (e.g., images) from the scan converter 830, the multiplanar reformatter 832, and/or the volume renderer 834 may be coupled to an image processor 836 for further enhancement, buffering and temporary storage before being displayed on an image display 838. The examiner notes that the imaging is a real time continuous imaging and the processor receives images and store them in real time before displaying them. Therefore, each new image replaces the prior one).
However, Vaidya fails to disclose that the ultrasound images are ULM images.
Errico, in the same field of endeavor, teaches ULM image (figure 2, pages 499-500; we demonstrate ultrafast ultrasound localization microscopy (uULM), which combines deep penetration and super-resolution imaging at unprecedented spatiotemporal resolution, by using clinically approved contrast agents: inert gas microbubbles. we were able to track each moving bubble according to its instantaneous position and in-plane velocity vector, leading to quantitative and localized maps of cerebral blood flow velocity. Hence, ultrafast imaging allows the reconstruction of entire organs within tens of seconds, a prerequisite for a preclinical and clinical modality.).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the at least one ultrasound image of Vaidya to incorporate the ULM ultrasound image of Errico. This modification will allow detailed reconstruction of entire organs within tens of seconds and allow small objects to be detected with high accuracy as disclosed within Errico in page 500.
Regarding claim 25, Vaidya teaches the system according to claim 14, wherein the target body structure is a vascular system of the brain (paras. 0021-0022; systems and methods of the invention are applicable for imaging and tracking devices in a variety of interventional procedures. Interventional procedures may include any procedure in which a physician inserts a device or tool into a patient's body to, e.g., biopsy, monitor, diagnose or treat. Exemplary interventional procedures may include, but are not limited to: arteriovenous malformations, angioplasty, biliary drainage and stenting, catheter embolization, central venous access, chemoembolization, gastrostomy tube insertion, hemodialysis access maintenance, balloon catheterization, needle biopsy, ablation, grafting, thrombolysis, shunting (e.g. transjugular intrahepatic portosystemic shunt), urinary catheterization, uterine catheterization, filter or stent implantation (e.g. vena cava filter). For example, systems and methods of the invention are well-suited for monitoring treatment of cardiovascular disease. In certain embodiments, the interventional device is configured for entry into one or more body lumens, and are imaged by the imaging elements. Various biological lumens include blood vessels, vasculature of the lymphatic and nervous systems, various structures of the gastrointestinal tract including lumen of the small intestine, large intestine, stomach, esophagus, colon, pancreatic duct, bile duct, hepatic duct, lumen of the reproductive tract including the vas deferens, vagina, uterus and fallopian tubes, structures of the urinary tract including urinary collecting ducts, renal tubules, ureter, and bladder, and structures of the head, neck and pulmonary system including sinuses, parotid, trachea, bronchi, and lungs. The examiner notes that the system is used to guide interventional device entry to one or more body lumens such as vasculature of the nervous system and structures in the head.).
Regarding claim 27, Vaidya teaches the system according to claim 14, wherein the system is for use in thrombectomy (paras. 0021-0022; systems and methods of the invention are applicable for imaging and tracking devices in a variety of interventional procedures. Interventional procedures may include any procedure in which a physician inserts a device or tool into a patient's body to, e.g., biopsy, monitor, diagnose or treat. Exemplary interventional procedures may include, but are not limited to: arteriovenous malformations, angioplasty, biliary drainage and stenting, catheter embolization, central venous access, chemoembolization, gastrostomy tube insertion, hemodialysis access maintenance, balloon catheterization, needle biopsy, ablation, grafting, thrombolysis, shunting (e.g. transjugular intrahepatic portosystemic shunt), urinary catheterization, uterine catheterization, filter or stent implantation (e.g. vena cava filter). For example, systems and methods of the invention are well-suited for monitoring treatment of cardiovascular disease. In certain embodiments, the interventional device is configured for entry into one or more body lumens, and are imaged by the imaging elements. Various biological lumens include blood vessels, vasculature of the lymphatic and nervous systems, various structures of the gastrointestinal tract including lumen of the small intestine, large intestine, stomach, esophagus, colon, pancreatic duct, bile duct, hepatic duct, lumen of the reproductive tract including the vas deferens, vagina, uterus and fallopian tubes, structures of the urinary tract including urinary collecting ducts, renal tubules, ureter, and bladder, and structures of the head, neck and pulmonary system including sinuses, parotid, trachea, bronchi, and lungs.).
Regarding claim 28, Vaidya teaches the system according to claim 14, wherein a new ultrasound image acquisition is launched, by the control unit, as soon a prior ultrasound image acquisition is terminated (paras. 0024, 0029, and 0032; The at least two imaging elements 120, 122 are configured to send imaging signals to and receive imaging signals from the region of interest within their respective field of views or a portion thereof. In certain embodiments, the imaging signals includes acoustic signals. In other embodiments, the imaging signals may be or also include photoacoustic signals. The received imaging signals of the region of interest can be used to generate one or more images. In certain embodiments, the received imaging signals generate a continuous imaging stream of the region of interest in real-time. Output (e.g., images) from the scan converter 830, the multiplanar reformatter 832, and/or the volume renderer 834 may be coupled to an image processor 836 for further enhancement, buffering and temporary storage before being displayed on an image display 838. The examiner notes that the imaging is a real time continuous imaging and the processor receives images and store them in real time before displaying them and continue to acquire new images.).
However, Vaidya fails to disclose that the ultrasound images are ULM images.
Errico, in the same field of endeavor, teaches ULM image (figure 2, pages 499-500; we demonstrate ultrafast ultrasound localization microscopy (uULM), which combines deep penetration and super-resolution imaging at unprecedented spatiotemporal resolution, by using clinically approved contrast agents: inert gas microbubbles. we were able to track each moving bubble according to its instantaneous position and in-plane velocity vector, leading to quantitative and localized maps of cerebral blood flow velocity. Hence, ultrafast imaging allows the reconstruction of entire organs within tens of seconds, a prerequisite for a preclinical and clinical modality.).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the at least one ultrasound image of Vaidya to incorporate the ULM ultrasound image of Errico. This modification will allow detailed reconstruction of entire organs within tens of seconds and allow small objects to be detected with high accuracy as disclosed within Errico in page 500.
Response to Arguments
Applicant’s arguments, see remarks, filed 06/22/2026, with respect to double patenting rejection have been fully considered and are persuasive. The double patenting rejection of the claims has been withdrawn.
Applicant's arguments filed 06/22/2026 have been fully considered but they are not persuasive. The applicant argues that the cited reference of Vaidya fails to teach or suggest a control unit with a memory configured to store at least one Ultrasound Localization Microscopy (ULM) ultrasound image of the target body structure, the control unit being configured to launch an acquisition of the least one ULM ultrasound image, the control unit being configured to localize the steerable element by means of ULM localization”. The applicant further argues that Vaidya merely generates continuous stream of conventional ultrasound images such as B-mode or Doppler images, using standard beamforming and analytical conversion pipeline, and does not disclose ULM acquisition. Applicant additionally argues that Vaidya fails to disclose displaying at least one stored ULM ultrasound image and display, in real time, the localization of the steerable element on said at least one stored ULM ultrasound image because Vaidya instead displays real time position of the steerable element on a continuous flow of ultrasound images.
The examiner respectfully disagree. Applicant’s arguments are considered but are not persuasive because the rejection does not rely upon Vaidya alone as teaching the recited ULM imaging features. Rather, Vaidya is relied upon for teaching ultrasound based localization, image registration, storage, and display, while Errico reference is relied upon for acquisition and generation of ULM images. Accordingly, applicant’s arguments that Vaidya does not itself disclose ULM acquisition does not address the combined teachings relied upon in the rejection.
In particular, Vaidya teaches imaging elements positioned relative to the patient and positional sensor associated with an interventional tool. The positional sensor receives ultrasound signals transmitted by the imaging elements, and the received signals are used to determine the position of the positional sensor and, consequently, the interventional tool. For example, the time delay between transmission of an ultrasound signal and reception of the signal by the positional sensor may be used to determine the position of the positional sensor whining the imaging beam. The process is repeated for a plurality of imaging signals to provide real-time tracking of the positional sensor and the interventional tool. Thus, contrary to applicant’s characterization, Vaidya reference does not merely disclose visually observing the steerable element within continuous stream of conventional ultrasound images. Rather, Vaidya expressly determine the location of the positional sensor from ultrasound signals and registers the determined location with an image generated by the imaging elements. The location of the position sensor/interventional tool is overlaid on the registered image, including by displaying a graphical element representing the position sensor. Therefore, Vaidya teaches real-time localization of an interventional tool and registration and display of that localization information relative to ultrasound image information.
Vaidya further teaches that output images from the scan converter, multiplanar reformatter, and/or volume renderer may be coupled to an image processor for further enhancement, buffering, and temporary storage before being displayed on the imaging display. As expressly disclosed in paras. 0032, 0035, and 0044, Vaidya disclose that generated ultrasound images may be buffered and temporarily stored before display, that images acquired from imaging elements may be independently reconstructed and register, and that the position of the positional sensor is independently determined and subsequently register to the fused image. Para. 0044 further expressly teaches that, once the location of the positional sensor is determined, its location may be overlaid on the registered image for enhanced visualization of the interventional tool.. Thus, Vaidya does not require the anatomical image and the localization information to constitute a single continuously updating image stream; rather, it teaches determining real time position information and combining that information with separately generated, registered, and stored image information.
Errico reference is relied upon for the additional teaching of acquiring ULM ultrasound data and generating ULM ultrasound images. One of ordinary skill in the art would have been motivated to employ the ULM imaging technique taught by Errico in the ultrasound imaging and tracking system of Vaidya to obtain the enhanced anatomical and/or microvascular visualization provided by ULM while retaining the Vaidya’s ultrasound based real-time localization of the interventional tool. In the resulting combination, the ULM ultrasound image provides the anatomical image information with which the determined real-time location of the positional sensor/interventional tool is registered and displayed.
Furthermore, the fact that Vaidya may describe continuous ultrasound imaging does not teach away from proposed combination. Vaidya does not require that localization information to be registered exclusively to a continuously updated B-mode or doppler image, not does it criticize or discourage registration of the determined tool position with previously acquired or stored ultrasound image information. indeed, its disclosure of buffering and temporary storage of image data before display is consistent with the use of stored image information for registration and visualization process.
Accordingly, applicant’s arguments that Vaidya alone fails to disclose ULM acquisition or display real time localization information on a stored ULM ultrasound image does not overcome the rejection, the rejection relied upon Vaidya for ultrasound based real time localization of the interventional tool and registration/display of the determined location with ultrasound image information, and upon Errico for acquisition and generation of ULM images. The combined teachings therefore teach or suggest the claimed real time localization information of the steerable element combined with and displayed relative to stored ULM ultrasound image information.
Applicant’s arguments that Errico does not address localization of a device inside the target body are not persuasive because they require Errico, considered individually, to disclose device localization functionality already taught by Vaidya. Vaidya teaches real time ultrasound localization of an interventional tool and registration and display of its determined position with ultrasound image information, while Errico is relied upon for teaching ULM acquisition. The fact that Errico generates a continuous flow of ULM images does not teach away from storing or using an acquired ULM image as an anatomical reference, as application has not identified any disclosure discouraging or rendering such use inoperable. Moreover, the combination does not require bodily incorporating the Errico’s entire continuous imaging implementation into Vaidya; rather, a person of ordinary skill in the art would have applied the ULM imaging technique of Errico to provide enhanced anatomical image information while retaining the Vaidya’s real time ultrasound localization, registration, and display functionality, thereby resulting in the claimed localization of the steerable element relative to the ULM image information.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZAINAB M ALDARRAJI whose telephone number is (571)272-8726. The examiner can normally be reached Monday-Thursday7AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carey Michael can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZAINAB MOHAMMED ALDARRAJI/Patent Examiner, Art Unit 3797
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