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 Objections
Claims 1, & 13-14 objected to because of the following informalities:
Claim 1 recites the limitation “an ultrasonic sensor” in the amended portion of the claim, should instead recite “the ultrasonic sensor”.
Claim 13 recites the limitation “an ultrasonic sensor” in the amended portion of the claim, should instead recite “the ultrasonic sensor”.
Claim 14 recites the limitation “an ultrasonic sensor” in the amended portion of the claim, should instead recite “the ultrasonic sensor”.
. Appropriate correction is required.
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, 6, 8-10, 13-15, & 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Silverstein et al (WO2012088535A1, hereinafter referred to as Silverstein) in view of Zheng et al (US20220280244A1; hereinafter referred to as Zheng).
Regarding Claim 1, Silverstein discloses a medical apparatus (system 1110) comprising a processor programmed to execute steps (“The system includes a processor that uses data relating to the detectable characteristic sensed by the sensors to determine a position and/or orientation of the needle in three spatial dimensions.” [0007]):
acquiring in-vivo ultrasonic information of inside of a living body obtained from an ultrasonic probe (1140) that has an ultrasonic sensor and is configured to emit ultrasonic waves inside the living body ("Reference is now made to FIGS. 22A and 22B, which show the ultrasound probe 1140 of the system 1110 and the needle 1200 in position and ready for insertion thereof through a skin surface 1220 of a patient to access a targeted internal body portion. In particular, the probe 1140 is shown with its head 1180 placed against the patient skin and producing an ultrasound beam 1222 so as to ultrasonically image a portion of a vessel 1226 beneath the patient skin surface 1220" [0093], see Fig 22A and 22B for the ultrasound probe imaging a live target);
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obtaining device magnetic field information relating to a magnetic field generated from a medical device (needle 1200) inserted in a blood vessel inside the living body ("Specifically, and as shown in FIGS. 22A and 22B, the position of the magnetic element 1210 in X, Y, and Z coordinate space with respect to the sensor array 1190 can be determined by the system 1110 using the magnetic field strength data sensed by the sensors 1192." [0095]);
generating an ultrasonic echo image of the blood vessel from the ultrasonic information, the ultrasonic echo image displaying the blood vessel on a scanning plane of the ultrasonic probe (“This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0095]);
and generating a device position image based on the ultrasonic echo image and the device magnetic field information (“This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0096], “The screenshot 1230 further shows a needle image 1234 representing the position and orientation of the actual needle 1200 as determined by the system 1110 as described above.” [0097]).
the device position image indicating whether the medical device is positioned on one side or positioned on another side of a reference plane that traverses the blood vessel ("Specifically, and as shown in FIGS. 22A and 22B, the position of the magnetic element 1210 in X, Y, and Z coordinate space with respect to the sensor array 1190 can be determined by the system 1110 using the magnetic field strength data sensed by the sensors 1192." [0095], “This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0096], the system is tracking the X, Y and Z coordinates of the medical device which when placed in the superimposed image would inherently show whether the device is on one side or another side of the reference planes generated by the scanning plane of the ultrasound probe outlined by a red box in Fig. 22A and 22B),
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wherein the reference plane is provided on the same plane as the scanning plane, and the scanning plane extends along a longitudinal axis of the blood vessel (“the probe 1140 is shown with its head 1180 placed against the patient skin and producing an ultrasound beam 1222 so as to ultrasonically image a portion of a vessel 1226 beneath the patient skin surface 1220. The ultrasonic image of the vessel 1226 can be depicted on the display 1130 of the system 1110 (FIG. 19).” [0093], see Fig. 22A and 22B to see the reference planes of the blood vessel, and Fig 23B for needle with respect to the planes).
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and in a stacking direction of a handle, a magnetic sensor, and an ultrasonic sensor, the handle is disposed above the magnetic sensor, the magnetic sensor is disposed above the ultrasonic sensor, and the ultrasonic sensor is disposed closer to a tissue-contact surface of the ultrasonic probe than the handle and the magnetic sensor (“The handheld probe 1140 includes a head 1180 that houses a piezoelectric array for producing ultrasonic pulses and for receiving echoes thereof after reflection by the patient's body when the head is placed against the patient's skin proximate the prospective insertion site 1173 (FIG. 19).” [0081], “As seen in FIG. 20, the probe 1140 includes a sensor array 1190 for detecting the position, orientation, and movement of the needle 1200 during ultrasound imaging procedures, such as those described above. As will be described in further detail below, the sensor array includes a plurality of magnetic sensors 1192 embedded within the housing of the probe. The sensors 1192 are configured to detect a magnetic field associated with the needle 1200 and enable the system 1110 to track the needle.” [0084], see Fig. 22a for the probe structure).
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Silverstein does not specifically teach the ultrasonic echo image comprises a cross-section of the blood vessel that extends along the longitudinal axis of the blood vessel.
However, in a similar field of endeavor, Zheng teaches systems, methods, and catheters for treatment of a blood vessel .
Zheng also teaches the ultrasonic echo image comprises a cross-section of the blood vessel that extends along the longitudinal axis of the blood vessel (“the imaging device is 2D ultrasound device or a 3D ultrasound device capable of capturing images of the desired blood vessel(s) along a frontal (coronal) plane, axial (transverse/cross-sectional) plane, and/or a sagittal plane)” [0185], “ based on the signals of the location sensor and/or the tracking sensor 1340, the control unit 1304 may determine a location of the treatment portion of the catheter and may be configured to automatically focus the settings of the imaging device to display various views of the treatment portion of the catheter including a sagittal view, an axial view, and/or a frontal view… Such views may cut through a center of the treatment portion of the catheter, such that each view shows a cross-sectional view of the catheter along in the sagittal plane, axial plane, and/or the frontal plane. FIG. 19A illustrates a display 1310 showing frontal plane view of a catheter 200 having a treatment portion being advanced through a vein V positioned proximate to an artery A in a frontal plane, axial plane, and a sagittal plane.” [0189])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Silverstein as outlined above with the ultrasonic echo image comprises a cross-section of the blood vessel that extends along the longitudinal axis of the blood vessel as taught by Zheng, because a need exists for techniques that improve alignment of the catheter within the blood vessel [0004].
Regarding Claim 3, Silverstein discloses that the ultrasonic probe includes a magnetic sensor having a fixed positional relationship with the ultrasonic sensor (“The handheld probe 1140 includes a head 1180 that houses a piezoelectric array for producing ultrasonic pulses and for receiving echoes thereof after reflection by the patient's body when the head is placed against the patient's skin proximate the prospective insertion site” [0083], “As seen in FIG. 20, the probe 1140 includes a sensor array 1190 … The sensors 1192 are configured to detect a magnetic field associated with the needle 1200 and enable the system 1110 to track the needle.” [0086])
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and the step of generating the device position image includes determining a positional relationship between the reference plane and the medical device using the positional relationship between the ultrasonic sensor and the magnetic sensor (“Specifically, and as shown in FIGS. 22A and 22B, the position of the magnetic element 1210 in X, Y, and Z coordinate space with respect to the sensor array 1190 can be determined by the system 1110 using the magnetic field strength data sensed by the sensors 1192. Moreover, FIG. 22A shows that the pitch of the magnetic element 1210 can also be determined, while FIG. 22B shows that the yaw of the magnetic element can be determined.” [0095], “This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0096].
Regarding Claim 6, Silverstein discloses that the processor is further programmed to execute a step of a synthetic image in which the ultrasonic echo image and the device position image are combined (“This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0096]).
Regarding Claim 8, Silverstein discloses that the step of generating the device position image includes generating the device position image ("Specifically, and as shown in FIGS. 22A and 22B, the position of the magnetic element 1210 in X, Y, and Z coordinate space with respect to the sensor array 1190 can be determined by the system 1110 using the magnetic field strength data sensed by the sensors 1192." [0095], “The screenshot 1230 further shows a needle image 1234 representing the position and orientation of the actual needle 1200 as determined by the system 1110 as described above.” [0097]),
in which an image indicating a position of the reference plane that traverses the blood vessel, and an image indicating a position of the medical device, are superimposed on an image representing a transverse cross-section of the blood vessel ("Specifically, and as shown in FIGS. 22A and 22B, the position of the magnetic element 1210 in X, Y, and Z coordinate space with respect to the sensor array 1190 can be determined by the system 1110 using the magnetic field strength data sensed by the sensors 1192." [0095], “This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0096], the system is tracking the X, Y and Z coordinates of the medical device which when placed in the superimposed image would show whether the device is one side or another side of the reference planes outlined by a red box in Fig. 22A and 22B),
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Regarding Claim 9, Silverstein discloses that the step of generating the device position image includes generating the device position image, in which a plane representing the reference plane that traverses the blood vessel, and a image of a distal end portion of the medical device, are superimposed on a image of the blood vessel ("Specifically, and as shown in FIGS. 22A and 22B, the position of the magnetic element 1210 in X, Y, and Z coordinate space with respect to the sensor array 1190 can be determined by the system 1110 using the magnetic field strength data sensed by the sensors 1192." [0095], “This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0096])
Silverstein does not specifically disclose a three-dimensional blood vessel image.
However, in a similar field of endeavor, Zheng teaches a three-dimensional blood vessel image (“Referring to FIG. 19B an example 3-Dimensional model 1312 of a portion of the vasculature of the subject. For example, where a catheter having a location sensor and/or echogenic marker is tracked through an artery or vein using an imaging device (e.g., 2D or 3D ultrasound device), the control unit 200 may generate a 3-Dimensional model 1312 of the artery or vein A/V and display the same on the display 1310.” [0189])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Silverstein as outlined above with generating a three-dimensional blood vessel image as taught by Zheng, because a need exists for techniques that improve alignment of the catheter within the blood vessel [0004].
Regarding Claim 10, Silverstein discloses that the processor is further programmed to execute a step of a synthetic image in which the ultrasonic echo image and the device position image are combined (“This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0096]).
Regarding Claim 13, Silverstein discloses an image generation method (method 1240) comprising ("a method 1240 for guiding a needle or other medical component includes various stages. At stage 1242, a targeted internal body portion of a patient is imaged by an imaging system, such as an ultrasound imaging device for instance.” [00187], “At stage 1244, a detectable characteristic of a medical component such as a needle is sensed by one or more sensors included with the imaging system." [0188]):
acquiring in-vivo ultrasonic information of inside of a living body obtained from an ultrasonic probe (1140) that has an ultrasonic sensor and is configured to emit ultrasonic waves inside the living body ("Reference is now made to FIGS. 22A and 22B, which show the ultrasound probe 1140 of the system 1110 and the needle 1200 in position and ready for insertion thereof through a skin surface 1220 of a patient to access a targeted internal body portion. In particular, the probe 1140 is shown with its head 1180 placed against the patient skin and producing an ultrasound beam 1222 so as to ultrasonically image a portion of a vessel 1226 beneath the patient skin surface 1220" [0093], see Fig 22A and 22B for the ultrasound probe imaging a live target);
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obtaining device magnetic field information relating to a magnetic field generated from a medical device (needle 1200) inserted in a blood vessel inside the living body ("Specifically, and as shown in FIGS. 22A and 22B, the position of the magnetic element 1210 in X, Y, and Z coordinate space with respect to the sensor array 1190 can be determined by the system 1110 using the magnetic field strength data sensed by the sensors 1192." [0095]);
generating an ultrasonic echo image of the blood vessel from the ultrasonic information, the ultrasonic echo image displaying the blood vessel on a scanning plane of the ultrasonic probe (“This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0095]);
and generating a device position image based on the ultrasonic echo image and the device magnetic field information (“This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0096], “The screenshot 1230 further shows a needle image 1234 representing the position and orientation of the actual needle 1200 as determined by the system 1110 as described above.” [0097]).
the device position image indicating whether the medical device is positioned on one side or positioned on another side of a reference plane that traverses the blood vessel ("Specifically, and as shown in FIGS. 22A and 22B, the position of the magnetic element 1210 in X, Y, and Z coordinate space with respect to the sensor array 1190 can be determined by the system 1110 using the magnetic field strength data sensed by the sensors 1192." [0095], “This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0096], the system is tracking the X, Y and Z coordinates of the medical device which when placed in the superimposed image would inherently show whether the device is on one side or another side of the reference planes generated by the scanning plane of the ultrasound probe outlined by a red box in Fig. 22A and 22B),
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wherein the reference plane is provided on the same plane as the scanning plane, and the scanning plane extends along a longitudinal axis of the blood vessel (“the probe 1140 is shown with its head 1180 placed against the patient skin and producing an ultrasound beam 1222 so as to ultrasonically image a portion of a vessel 1226 beneath the patient skin surface 1220. The ultrasonic image of the vessel 1226 can be depicted on the display 1130 of the system 1110 (FIG. 19).” [0093], see Fig. 22A and 22B to see the reference planes of the blood vessel, and Fig 23B for needle with respect to the planes).
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and in a stacking direction of a handle, a magnetic sensor, and an ultrasonic sensor, the handle is disposed above the magnetic sensor, the magnetic sensor is disposed above the ultrasonic sensor, and the ultrasonic sensor is disposed closer to a tissue-contact surface of the ultrasonic probe than the handle and the magnetic sensor (“The handheld probe 1140 includes a head 1180 that houses a piezoelectric array for producing ultrasonic pulses and for receiving echoes thereof after reflection by the patient's body when the head is placed against the patient's skin proximate the prospective insertion site 1173 (FIG. 19).” [0081], “As seen in FIG. 20, the probe 1140 includes a sensor array 1190 for detecting the position, orientation, and movement of the needle 1200 during ultrasound imaging procedures, such as those described above. As will be described in further detail below, the sensor array includes a plurality of magnetic sensors 1192 embedded within the housing of the probe. The sensors 1192 are configured to detect a magnetic field associated with the needle 1200 and enable the system 1110 to track the needle.” [0084], see Fig. 22a for the probe structure).
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Silverstein does not specifically teach the ultrasonic echo image comprises a cross-section of the blood vessel that extends along the longitudinal axis of the blood vessel.
However, in a similar field of endeavor, Zheng teaches systems, methods, and catheters for treatment of a blood vessel .
Zheng also teaches the ultrasonic echo image comprises a cross-section of the blood vessel that extends along the longitudinal axis of the blood vessel (“the imaging device is 2D ultrasound device or a 3D ultrasound device capable of capturing images of the desired blood vessel(s) along a frontal (coronal) plane, axial (transverse/cross-sectional) plane, and/or a sagittal plane)” [0185], “ based on the signals of the location sensor and/or the tracking sensor 1340, the control unit 1304 may determine a location of the treatment portion of the catheter and may be configured to automatically focus the settings of the imaging device to display various views of the treatment portion of the catheter including a sagittal view, an axial view, and/or a frontal view… Such views may cut through a center of the treatment portion of the catheter, such that each view shows a cross-sectional view of the catheter along in the sagittal plane, axial plane, and/or the frontal plane. FIG. 19A illustrates a display 1310 showing frontal plane view of a catheter 200 having a treatment portion being advanced through a vein V positioned proximate to an artery A in a frontal plane, axial plane, and a sagittal plane.” [0189])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Silverstein as outlined above with the ultrasonic echo image comprises a cross-section of the blood vessel that extends along the longitudinal axis of the blood vessel as taught by Zheng, because a need exists for techniques that improve alignment of the catheter within the blood vessel [0004].
Regarding Claim 14, Silverstein discloses a non-transitory computer readable storage medium having stored therein a program to be executed by a processor, the program causing the processor to execute the steps of ("The system includes a processor that uses data relating to the detectable characteristic sensed by the sensors to determine a position and/or orientation of the needle in three spatial dimensions." [0007], “The system 10 further includes ports 52 for connection with the sensor 50 and optional components 54 including a printer, storage media, keyboard, etc.” [0104]):
acquiring in-vivo ultrasonic information of inside of a living body obtained from an ultrasonic probe (1140) that has an ultrasonic sensor and is configured to emit ultrasonic waves inside the living body ("Reference is now made to FIGS. 22A and 22B, which show the ultrasound probe 1140 of the system 1110 and the needle 1200 in position and ready for insertion thereof through a skin surface 1220 of a patient to access a targeted internal body portion. In particular, the probe 1140 is shown with its head 1180 placed against the patient skin and producing an ultrasound beam 1222 so as to ultrasonically image a portion of a vessel 1226 beneath the patient skin surface 1220" [0093], see Fig 22A and 22B for the ultrasound probe imaging a live target);
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obtaining device magnetic field information relating to a magnetic field generated from a medical device (needle 1200) inserted in a blood vessel inside the living body ("Specifically, and as shown in FIGS. 22A and 22B, the position of the magnetic element 1210 in X, Y, and Z coordinate space with respect to the sensor array 1190 can be determined by the system 1110 using the magnetic field strength data sensed by the sensors 1192." [0095]);
generating an ultrasonic echo image of the blood vessel from the ultrasonic information, the ultrasonic echo image displaying the blood vessel on a scanning plane of the ultrasonic probe (“This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0095], “The screenshot 1230 further shows a needle image 1234 representing the position and orientation of the actual needle 1200 as determined by the system 1110 as described above.” [0097]);
and generating a device position image based on the ultrasonic echo image and the device magnetic field information (“This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0096]).
the device position image indicating whether the medical device is positioned on one side or positioned on another side of a reference plane that traverses the blood vessel ("Specifically, and as shown in FIGS. 22A and 22B, the position of the magnetic element 1210 in X, Y, and Z coordinate space with respect to the sensor array 1190 can be determined by the system 1110 using the magnetic field strength data sensed by the sensors 1192." [0095], “This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0096], the system is tracking the X, Y and Z coordinates of the medical device which when placed in the superimposed image would inherently show whether the device is on one side or another side of the reference planes generated by the scanning plane of the ultrasound probe outlined by a red box in Fig. 22A and 22B),
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wherein the reference plane is provided on the same plane as the scanning plane, and the scanning plane extends along a longitudinal axis of the blood vessel (“the probe 1140 is shown with its head 1180 placed against the patient skin and producing an ultrasound beam 1222 so as to ultrasonically image a portion of a vessel 1226 beneath the patient skin surface 1220. The ultrasonic image of the vessel 1226 can be depicted on the display 1130 of the system 1110 (FIG. 19).” [0093], see Fig. 22A and 22B to see the reference planes of the blood vessel).
and in a stacking direction of a handle, a magnetic sensor, and an ultrasonic sensor, the handle is disposed above the magnetic sensor, the magnetic sensor is disposed above the ultrasonic sensor, and the ultrasonic sensor is disposed closer to a tissue-contact surface of the ultrasonic probe than the handle and the magnetic sensor (“The handheld probe 1140 includes a head 1180 that houses a piezoelectric array for producing ultrasonic pulses and for receiving echoes thereof after reflection by the patient's body when the head is placed against the patient's skin proximate the prospective insertion site 1173 (FIG. 19).” [0081], “As seen in FIG. 20, the probe 1140 includes a sensor array 1190 for detecting the position, orientation, and movement of the needle 1200 during ultrasound imaging procedures, such as those described above. As will be described in further detail below, the sensor array includes a plurality of magnetic sensors 1192 embedded within the housing of the probe. The sensors 1192 are configured to detect a magnetic field associated with the needle 1200 and enable the system 1110 to track the needle.” [0084], see Fig. 22a for the probe structure).
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Silverstein does not specifically teach the ultrasonic echo image comprises a cross-section of the blood vessel that extends along the longitudinal axis of the blood vessel.
However, in a similar field of endeavor, Zheng teaches systems, methods, and catheters for treatment of a blood vessel .
Zheng also teaches the ultrasonic echo image comprises a cross-section of the blood vessel that extends along the longitudinal axis of the blood vessel (“the imaging device is 2D ultrasound device or a 3D ultrasound device capable of capturing images of the desired blood vessel(s) along a frontal (coronal) plane, axial (transverse/cross-sectional) plane, and/or a sagittal plane)” [0185], “ based on the signals of the location sensor and/or the tracking sensor 1340, the control unit 1304 may determine a location of the treatment portion of the catheter and may be configured to automatically focus the settings of the imaging device to display various views of the treatment portion of the catheter including a sagittal view, an axial view, and/or a frontal view… Such views may cut through a center of the treatment portion of the catheter, such that each view shows a cross-sectional view of the catheter along in the sagittal plane, axial plane, and/or the frontal plane. FIG. 19A illustrates a display 1310 showing frontal plane view of a catheter 200 having a treatment portion being advanced through a vein V positioned proximate to an artery A in a frontal plane, axial plane, and a sagittal plane.” [0189])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Silverstein as outlined above with the ultrasonic echo image comprises a cross-section of the blood vessel that extends along the longitudinal axis of the blood vessel as taught by Zheng, because a need exists for techniques that improve alignment of the catheter within the blood vessel [0004].
Regarding Claim 15, Silverstein discloses that the medical device comprises a magnetic field generation unit (“The sensors 1192 are configured to continuously detect the magnetic field of the magnetic element 1210 of the needle 1200 during operation of the system 1110” [0098]),
and the processor is further programmed to execute a step of identifying a positional relationship between the reference plane and the device magnetic field generation unit (“The above position and orientation information determined by the system 1110, together with the length of the cannula 1202 and position of the magnetic element 1210 with respect to the distal needle tip as known by or input into the system, enable the system to accurately determine the location and orientation of the entire length of the needle 1200 with respect to the sensor array 1190.” [0096]).
Regarding Claim 18, Silverstein discloses that the reference plane traverses a maximum diameter of the blood vessel in the image representing a transverse cross-section of the blood vessel (“Specifically, and as shown in FIGS. 22A and 22B, the position of the magnetic element 1210 in X, Y, and Z coordinate space with respect to the sensor array 1190 can be determined by the system 1110 using the magnetic field strength data sensed by the sensors 1192. Moreover, FIG. 22A shows that the pitch of the magnetic element 1210 can also be determined, while FIG. 22B shows that the yaw of the magnetic element can be determined.” [0095], as seen in Fig. 22B the ultrasonic beam comprises the entirety of the blood vessel which would include the maximum diameter of the blood vessel).
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Regarding Claim 19, Silverstein discloses that the medical device in the ultrasonic echo image is surrounded within the blood vessel in the ultrasonic echo image displaying the blood vessel on the scanning plane of the ultrasonic probe (“Specifically, and as shown in FIGS. 22A and 22B, the position of the magnetic element 1210 in X, Y, and Z coordinate space with respect to the sensor array 1190 can be determined by the system 1110 using the magnetic field strength data sensed by the sensors 1192. Moreover, FIG. 22A shows that the pitch of the magnetic element 1210 can also be determined, while FIG. 22B shows that the yaw of the magnetic element can be determined.” [0095], as seen in Fig. 22B the medical device during the procedure would be completely enveloped by the blood vessel).
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Claims 2, 4-5, 7, 11-12, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Silverstein in view of Zheng as applied to Claim 1 above, and further in view of Seitel et al (US20200187900A1; hereinafter referred to as Seitel).
Regarding Claim 2, Silverstein in view of Zheng discloses that the processor is further programmed to execute a step of acquiring probe magnetic field information relating to a magnetic field, and the step of generating the device position image includes defining the reference by the magnetic field information ("Specifically, and as shown in FIGS. 22A and 22B, the position of the magnetic element 1210 in X, Y, and Z coordinate space with respect to the sensor array 1190 can be determined by the system 1110 using the magnetic field strength data sensed by the sensors 1192." [Silverstein 0095]).
Silverstein in view of Zheng does not specifically disclose that the ultrasonic probe includes a magnetic field generation unit, generating a magnetic field.
However, in the similar field of image guided ultrasound systems, Seitel teaches a mounting device for reversibly mounting at least one electromagnetic field generator on an ultrasonic probe for orientating the electromagnetic field generator with respect to the ultrasonic probe [Abstract].
Seitel also teaches that the ultrasonic probe includes a magnetic field generation unit, generating a magnetic field (“FIG. 1 shows a mounting device 110 for reversibly mounting at least one electromagnetic field generator 112 on an ultrasonic probe 114 for orienting the electromagnetic field generator 112 with respect to the ultrasonic probe 114 in at least one mounting position 116” [0049]),
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Silverstein in view of Zheng as outlined above with the ultrasonic probe includes a magnetic field generation unit, generating a magnetic field as taught by Seitel, because continuous localization of the instrument relative to the anatomy localized in the ultrasonic image can be facilitated by an application of an electromagnetic field generated by an electromagnetic field generator [0002].
Regarding Claim 4, Silverstein discloses that the step of generating the device position image includes generating the device position image, in which an image indicating a position of the reference plane that traverses the blood vessel (“the probe 1140 is shown with its head 1180 placed against the patient skin and producing an ultrasound beam 1222 so as to ultrasonically image a portion of a vessel 1226 beneath the patient skin surface 1220. The ultrasonic image of the vessel 1226 can be depicted on the display 1130 of the system 1110 (FIG. 19).” [0093], see Fig. 22A and 22B to see the reference planes of the blood vessel),
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and an image indicating a position of the medical device, are superimposed on an image representing a transverse cross-section of the blood vessel ("Specifically, and as shown in FIGS. 22A and 22B, the position of the magnetic element 1210 in X, Y, and Z coordinate space with respect to the sensor array 1190 can be determined by the system 1110 using the magnetic field strength data sensed by the sensors 1192." [0095], “This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0096], the system is tracking the X, Y and Z coordinates of the medical device which when placed in the superimposed image would show whether the device in the reference planes outlined by a red box in Fig. 22A and 22B).
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Regarding Claim 5, Silverstein discloses that the step of generating the device position image includes generating the device position image, in which a plane representing the reference plane that traverses the blood vessel, and a image of a distal end portion of the medical device, are superimposed on a image of the blood vessel ("Specifically, and as shown in FIGS. 22A and 22B, the position of the magnetic element 1210 in X, Y, and Z coordinate space with respect to the sensor array 1190 can be determined by the system 1110 using the magnetic field strength data sensed by the sensors 1192." [0095], “This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0096])
Silverstein does not specifically disclose a three-dimensional blood vessel image.
However, in a similar field of endeavor, Zheng teaches a three-dimensional blood vessel image (“Referring to FIG. 19B an example 3-Dimensional model 1312 of a portion of the vasculature of the subject. For example, where a catheter having a location sensor and/or echogenic marker is tracked through an artery or vein using an imaging device (e.g., 2D or 3D ultrasound device), the control unit 200 may generate a 3-Dimensional model 1312 of the artery or vein A/V and display the same on the display 1310.” [0189])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Silverstein as outlined above with generating a three-dimensional blood vessel image as taught by Zheng, because a need exists for techniques that improve alignment of the catheter within the blood vessel [0004].
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Regarding Claim 7, Silverstein discloses that the processor is further programmed to execute a step of a synthetic image in which the ultrasonic echo image and the device position image are combined (“This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0096]).
Regarding Claim 11, Silverstein discloses that the processor is further programmed to execute a step of a synthetic image in which the ultrasonic echo image and the device position image are combined (“This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0096]).
Regarding Claim 12, Silverstein discloses that the processor is further programmed to execute a step of a synthetic image in which the ultrasonic echo image and the device position image are combined (“This in turn enables the system 1110 to superimpose an image of the needle 1200 on to an image produced by the ultrasound beam 1222 of the probe 1140. FIGS. 23A and 23B show examples of such a superimposition of the needle onto an ultrasound image. Specifically, FIGS. 23A and 23B each show a screenshot 1230 that can be depicted on the display 1130 (FIG. 19)" [0096]).
Regarding Claim 16, Silverstein discloses that the system may comprise at least two magnetic field generation units (“it is appreciated that many other types, numbers, and sizes of magnetic elements can be employed with the needle 1200 or other medical component to enable tracking thereof by the present guidance system.” [0092]),
Silverstein does not specifically disclose that the ultrasonic probe includes a magnetic field generation unit, and the ultrasonic sensor is arranged on a straight line connecting two magnetic field generation units.
However, in the similar field of image guided ultrasound systems, Seitel teaches that the ultrasonic probe includes a magnetic field generation unit (“FIG. 1 shows a mounting device 110 for reversibly mounting at least one electromagnetic field generator 112 on an ultrasonic probe 114 for orienting the electromagnetic field generator 112 with respect to the ultrasonic probe 114 in at least one mounting position 116” [0049]),
and the ultrasonic sensor is arranged on a straight line connecting the magnetic field generation unit (“FIG. 1 shows a mounting device 110 for reversibly mounting at least one electromagnetic field generator 112 on an ultrasonic probe 114 for orienting the electromagnetic field generator 112 with respect to the ultrasonic probe 114 in at least one mounting position 116.” [0049], as seen in Fig. 1 the magnetic field generation unit is in a straight line with ultrasonic sensors 114).
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Regarding Claim 17, Silverstein discloses that the reference plane traverses a maximum diameter of the blood vessel in the image representing a transverse cross-section of the blood vessel (“Specifically, and as shown in FIGS. 22A and 22B, the position of the magnetic element 1210 in X, Y, and Z coordinate space with respect to the sensor array 1190 can be determined by the system 1110 using the magnetic field strength data sensed by the sensors 1192. Moreover, FIG. 22A shows that the pitch of the magnetic element 1210 can also be determined, while FIG. 22B shows that the yaw of the magnetic element can be determined.” [0095], as seen in Fig. 22B the ultrasonic beam comprises the entirety of the blood vessel which would include the maximum diameter of the blood vessel).
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Response to Arguments
Applicant's arguments filed 09/30/2025 have been fully considered but they are not persuasive.
Regarding the U.S.C. 103 rejection of Claims 1-19 the applicant argues the following:
Silverstein fails to disclose this configuration where "the magnetic sensor and the
magnetic sensor is disposed above the ultrasonic sensor." Rather, as illustrated in Figs. 22A and 22B the magnetic sensor 1192 is disposed on a side surface of the device. Additionally, Silverstein fails to disclose a handle that is above the magnetic sensor in a vertical line. If anything, the figures in Silverstein appear to show the user would grip the device similar to gripping a pen or pencil. Therefore, Silverstein does not disclose a configuration wherein the handle, magnetic sensor, and ultrasonic sensor are stacked in a vertical line.
However, it is noted that under the broadest reasonable interpretation of Claim 1 all that is needed is the following order from the reference of the imaged vessel: a probe handle above a magnetic sensor above an ultrasonic sensor above the imaged tissue. There is no mention of a vertical line between the 3 nor is there mention of the grip of the user being pertinent to the claim set.
Silverstein teaches a probe configuration where the probe handle (seen in Fig.22a) is above the magnetic sensors (1192) above the ultrasonic sensors in the head (1180 [0081]) which is above imaged vessel (1222).
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The magnetic sensor 1192 being on the side of the probe has no effect on the limitation since the limitation is describing the stack in reference to the scanning plane and processor order of function not the physical structure of the probe components.
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 STEVEN MALDONADO whose telephone number is 703-756-1421. The examiner can normally be reached 8:00 am-4:00 pm PST M-Th Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at
http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached on (571) 272-7230. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Steven Maldonado/
Patent Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797