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 .
Response to Amendment
This office action is in response to the remarks filed on 01/30/2026.
The amendment filed 01/30/2026 has been entered. Claims 1-4, 8-15, and 19-20 remain pending in the application, claims 5-7 and 16-18 have been canceled, and claims 21-26 have been newly added.
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 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 1-5, 7-8,10-15, 17-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Burnside et al. (US 10231753 B2, of record, hereinafter "Burnside") in view of Xia et al. (US 20210307838 A1, hereinafter "Xia").
Regarding claim 1, Burnside teaches an ultrasound system, comprising:
an ultrasound probe including a probe head (The handheld probe 1140 includes a head 1180, col 19 line 4), a body (body of probe shown in fig.20), and a magnetic sensor, the magnetic sensor configured to detect a magnetic field generated by or associated with a needle (One or more sensors are included with the probe. The sensors sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle, Col 1 lines 62-65; [fig. 20] with probe 1140 and sensors 1192 reproduced below; the needle 1200 that can be used in connection with the guidance system 1110 …. the needle 1200 includes a hollow cannula 1202, ….open end 1204A of the hub 1204 is in communication with the hollow cannula 1202 such that a guide wire, stylet, or other component may be passed through the hub into the cannula, col. 20 lines 9-23; [fig. 21a] with needle 1200 reproduced below);
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Fig. 20 and 21a of Burnside reproduced above
a display for depicting a virtual image of the needle over an ultrasound image of a blood vessel in accordance with needle tracking for the needle (Thus, the single display 30 of the system console 20 can be employed for ultrasound guidance in accessing a patient's vasculature, TLS guidance during catheter advancement through the vasculature, Col. 5 lines 45-47); and
logic stored on non-transitory computer-readable medium that, when executed by one or more processors, causes performance of operations including (A processor 22, including non-volatile memory such as EEPROM for instance, is included in the console 20 for controlling system function during operation of the system 10, thus acting as a control processor, Col 5 lines 12-16):
receiving an indication that the magnetic field has been detected including a strength of the magnetic field (the display screenshot will indicate “no signal,” indicating that the magnetic field from the stylet magnetic assembly has not been detected, Col. 9 lines 14-16; in FIG. 29 the needle 1200 includes a stylet 1298 disposed therein. The stylet 1298 includes an EM coil …included in the probe 1140 or system console 1120 such that the EM coil emits an EM signal during operation, col. 10 lines 10-16)
determining a distance between a distal tip of the needle (the magnetic elements 106 of the stylet magnetic assembly are co-terminal with the distal end 76A of the catheter 72 (FIG. 2), detection by the TLS sensor 50 of the magnetic field of the magnetic elements provides information to the clinician as to the position and orientation of the catheter distal end during its transit, Col. 8 lines 23-28) and the ultrasound probe based on the strength of the magnetic field (suitable algorithms are performed by the processor 1122 to calculate a magnetic field strength of the magnetic element 1210 of the needle 1200 at predicted points in space in relationship to the probe, Col 23 lines 38-42).
Burnside, however, does not teach generating increasingly cautionary alerts within predetermined thresholds of the distance between the distal tip of the needle and the ultrasound probe, the increasingly cautionary alerts configured to protect against breaching the probe head with the distal tip of the needle while the needle is advanced by a clinician to the blood vessel under the probe head.
Xia is considered analogous to the instant application as “Surgical navigation method and system” is disclosed (title). Xia teaches:
generating increasingly cautionary alerts within predetermined thresholds of the distance between the distal tip of the needle and the ultrasound probe, the increasingly cautionary alerts configured to protect against breaching the probe head with the distal tip of the needle while the needle is advanced by a clinician to the blood vessel under the probe head (according to the three-dimensional tracking information of the puncture needle 101 and the ultrasound probe 102 and the ultrasound image, the puncture needle trajectory generating module transforms the coordinates of the puncture needle into the ultrasound image in the second coordinate system, …. The position and the trajectory of the puncture needle in the ultrasound image are therefore calculated and displayed by the display module [0103]; [0054] discloses tracking the needle with respect to the ultrasound probe in the second coordinate system in the ultrasound image; an alert module, configured to give an alert when the offset distance of the puncture needle relative to the ultrasound image or the distance between the puncture needle and the target puncture area is smaller than a preset threshold [0038]; probe head and tracking point depicted in fig. 7).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Burnside, by including generating increasingly cautionary alerts within predetermined thresholds of the distance between the distal tip of the needle and the ultrasound probe, the increasingly cautionary alerts configured to protect against breaching the probe head with the distal tip of the needle while the needle is advanced by a clinician to the blood vessel under the probe head, as taught by Xia. Doing so would allow for, the doctor can handle the puncture direction of the surgery intuitively and efficiently, as suggested by Xia ([0049]).
Regarding claim 2, the combined invention as modified above teaches the claimed invention as discussed above. Burnside further teaches a system further comprising a console apparatus that includes the non-transitory computer-readable medium, the console apparatus communicatively coupled to the ultrasound probe (A processor 1122, including non-volatile memory such as EEPROM for instance, is included in the console 1120 for controlling system function and executing various algorithms during operation of the system 1110, thus acting as a control processor; Col. 5 lines 12-20).
Regarding claim 3, the combined invention as modified above as modified above teaches the claimed invention as discussed above. Burnside further teaches a system wherein the magnetic sensor includes a sensor array including a plurality of sensors (the sensor array includes a plurality of magnetic sensors, Col. 19 lines 35-36), the magnetic sensor being detachable ( the sensor array need not be incorporated natively into the ultrasound imaging device, but can be included therewith in other ways. FIG. 25 shows one example of this, wherein an attachable sensor module 1260 including the sensors 1192 of the sensor array 1190 is shown attached to the ultrasound probe 1140. Such a configuration enables needle guidance as described herein to be achieved in connection with a standard ultrasound imaging device, i.e., a device not including a sensor array integrated into the ultrasound probe or a processor and algorithms configured to locate and track a needle as described above, col. 24 lines 40-51).
Regarding claim 4, the combined invention as modified above teaches the claimed invention as discussed above. Burnside further teaches a system wherein the logic, when executed by the one or more processors, causes performance of further operations including:
determining a positioning of the needle in three spatial dimensions including X, Y, Z coordinate space (to enable detection of the needle 1200 in not only the three spatial dimensions (i.e., X, Y, Z coordinate space), Col. 19 lines 63-66); and
determining a pitch, attitude, and a yaw attitude of the needle (five sensors 1192 are included in the sensor array 1190 so as to enable detection of the needle 1200 in not only the three spatial dimensions (i.e., X, Y, Z coordinate space), but also the pitch and yaw orientation of the needle itself, col 19 lines 62-65).
Regarding claim 8, the combined invention as modified above teaches the claimed invention as discussed above. Burnside further teaches a system wherein the magnetic sensor is located at a distal end of the ultrasound probe (the magnetic sensors 1192 are implicitly located on the distal end/head 1180 of the probe 1140 as seen in Fig 20; Col 19 lines 42-50).
Regarding claim 10, the combined invention as modified above teaches the claimed invention as discussed above. Burnside further teaches a system wherein the magnetic sensor is a three-axis sensor configured to detect corresponding orthogonal components of the magnetic field (the sensor 1294 is a three-axis sensor for detecting corresponding orthogonal components of the EM signal, Col 26 lines 19-21).
Regarding claim 11, Burnside teaches a method of accessing a vasculature of a patient under ultrasonic image guidance, the method comprising: providing:
a needle (The sensors sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle, Col 1 lines 62-65) ,
an ultrasound imaging system, including an ultrasound probe ( [fig. 20] with probe 1140 and sensors 1192 reproduced below), including a probe head (The handheld probe 1140 includes a head 1180, col 19 line 4), a body(body of probe shown in fig.20) and a magnetic sensor, the magnetic sensor being configured to detect a magnetic field generated by or associated with the needle (One or more sensors are included with the probe. The sensors sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle, Col 1 lines 62-65; the ultrasound probe inherently includes a body; the needle 1200 that can be used in connection with the guidance system 1110 …. the needle 1200 includes a hollow cannula 1202, ….open end 1204A of the hub 1204 is in communication with the hollow cannula 1202 such that a guide wire, stylet, or other component may be passed through the hub into the cannula, col. 20 lines 9-23; [fig. 21a] with needle 1200 reproduced below); , and
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Fig. 20 and 21a of Burnside reproduced above
a display for depicting a virtual image of the needle over an ultrasound image of a blood vessel in accordance with needle tracking for the needle (Thus, the single display 30 of the system console 20 can be employed for ultrasound guidance in accessing a patient's vasculature, TLS guidance during catheter advancement through the vasculature, Col. 5 lines 45-47); and
advancing the needle toward a skin surface of a patient to access the blood vessel with the needle by penetrating the skin surface (Figs 22A and 22B…the needle 1200 in position and ready for insertion thereof through a skin surface 1220 of a patient…a portion of a vessel 1226 beneath the patient skin surface 122, Col. 20 lines 39-46; [figs 22a and 22b] reproduced below)
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Figs. 22A and 22B of Burnside reproduced above
wherein logic, stored on a non-transitory computer-readable medium, when executed by one or more processors, causes performance of operations including (A processor 22, including non-volatile memory such as EEPROM for instance, is included in the console 20 for controlling system function during operation of the system 10, thus acting as a control processor, Col 5 lines 12-16):
receiving an indication that the magnetic field has been detected including a strength of the magnetic field (the display screenshot will indicate “no signal,” indicating that the magnetic field from the stylet magnetic assembly has not been detected, Col. 9 lines 14-16; in FIG. 29 the needle 1200 includes a stylet 1298 disposed therein. The stylet 1298 includes an EM coil …included in the probe 1140 or system console 1120 such that the EM coil emits an EM signal during operation, col. 10 lines 10-16),
determining a distance between a distal tip of the needle (the magnetic elements 106 of the stylet magnetic assembly are co-terminal with the distal end 76A of the catheter 72 (FIG. 2), detection by the TLS sensor 50 of the magnetic field of the magnetic elements provides information to the clinician as to the position and orientation of the catheter distal end during its transit, Col. 8 lines 23-28) and the probe based on the strength of the magnetic field (suitable algorithms are performed by the processor 1122 to calculate a magnetic field strength of the magnetic element 1210 of the needle 1200 at predicted points in space in relationship to the probe, Col 23 lines 38-42).
Burnside does not teach generating increasingly cautionary alerts within predetermined thresholds of the distance between the distal tip of the needle and the ultrasound probe, the increasingly cautionary alerts configured to protect against breaching the probe head with the distal tip of the needle while the needle is advanced to the blood vessel under the probe head.
Xia is considered analogous to the instant application as “Surgical navigation method and system” is disclosed (title). Xia teaches:
generating increasingly cautionary alerts within predetermined thresholds of the distance between the distal tip of the needle and the ultrasound probe, the increasingly cautionary alerts configured to protect against breaching the probe head with the distal tip of the needle while the needle is advanced by a clinician to the blood vessel under the probe head (according to the three-dimensional tracking information of the puncture needle 101 and the ultrasound probe 102 and the ultrasound image, the puncture needle trajectory generating module transforms the coordinates of the puncture needle into the ultrasound image in the second coordinate system, …. The position and the trajectory of the puncture needle in the ultrasound image are therefore calculated and displayed by the display module [0103]; [0054] discloses tracking the needle with respect to the ultrasound probe in the second coordinate system in the ultrasound image; an alert module, configured to give an alert when the offset distance of the puncture needle relative to the ultrasound image or the distance between the puncture needle and the target puncture area is smaller than a preset threshold [0038]; probe head and tracking point depicted in fig. 7).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Burnside, by including generating increasingly cautionary alerts within predetermined thresholds of the distance between the distal tip of the needle and the ultrasound probe, the increasingly cautionary alerts configured to protect against breaching the probe head with the distal tip of the needle while the needle is advanced by a clinician to the blood vessel under the probe head, as taught by Xia. Doing so would allow for, the doctor can handle the puncture direction of the surgery intuitively and efficiently, as suggested by Xia ([0049]).
Regarding claim 12, the combined invention as modified above teaches the claimed invention as discussed above. Burnside further teaches a method further comprising providing a console apparatus that includes the non-transitory computer-readable medium, the console apparatus communicatively coupled to the ultrasound probe (A processor 1122, including non-volatile memory such as EEPROM for instance, is included in the console 1120 for controlling system function and executing various algorithms during operation of the system 1110, thus acting as a control processor; Col. 5 lines 12-20).
Regarding claim 13, the combined invention as modified above teaches the claimed invention as discussed above. Burnside further teaches a method wherein the magnetic sensor is a three-axis sensor configured to detect corresponding orthogonal components of the magnetic field (the sensor 1294 is a three-axis sensor for detecting corresponding orthogonal components of the EM signal, Col 26 lines 19-21).
Regarding claim 14, the combined invention as modified above teaches the claimed invention as discussed above. Burnside further teaches a method wherein the logic detects a positioning of the needle in three spatial dimensions including X, Y, Z coordinate space (to enable detection of the needle 1200 in not only the three spatial dimensions (i.e., X, Y, Z coordinate space), Col. 19 lines 63-66).
Regarding claim 15, the combined invention as modified above teaches the claimed invention as discussed above. Burnside further teaches a method wherein the logic further detects a pitch attitude and a yaw attitude of the needle (pitch and yaw orientation of the needle, Col. 19 lines 63-66).
Regarding claim 20, the combined invention as modified above teaches the claimed invention as discussed above. Burnside further teaches attaching the magnetic sensor to the ultrasound probe (the sensor array need not be incorporated natively into the ultrasound imaging device, but can be included therewith in other ways. FIG. 25 shows one example of this, wherein an attachable sensor module 1260 including the sensors 1192 of the sensor array 1190 is shown attached to the ultrasound probe 1140. Such a configuration enables needle guidance as described herein to be achieved in connection with a standard ultrasound imaging device, i.e., a device not including a sensor array integrated into the ultrasound probe or a processor and algorithms configured to locate and track a needle as described above, col. 24 lines 40-51), wherein the magnetic sensor includes a sensor array comprising a plurality of sensors disposed in a planar configuration below a top face of the ultrasound probe when attached (the sensors 1192 are disposed in a planar configuration below a top face 1182 of the probe 1140, Col. 19 lines 46-47).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Burnside et al. (US 10231753 B2, of record, hereinafter "Burnside") in view of Xia et al. (US 20210307838A1, hereinafter "Xia") and Gubbini et al (US 20140163382 A1, hereinafter "Gubbini").
Regarding claim 9, modified Burnside teaches ultrasound system of claim 1, as discussed above. Burnside, however, does not teach a needle shield coupled to the probe head, the needle shield formed of a resilient material that is transparent to acoustic energy and resistant to penetrations from the needle.
Gubbini is considered analogous to the instant application as “Ultrasound apparatus cover” is disclosed (title). Gubbini teaches a needle shield (100; fig. 3 ) coupled to the probe head (a probe head 216 [0028]; fig. 3; cover 100 attached to probe head 216 as shown in fig. 3), the needle shield formed of a resilient material (The ultrasound apparatus cover 100 is generally rigid and pre-formed (e.g., thermo, injection mold, or otherwise formed) so that the first side geometrically conforms to a shape of at least a portion of the ultrasound apparatus 102 that includes the acoustic window/lens 106 [0021]) that is transparent to acoustic energy and resistant to penetrations from the needle (The ultrasound apparatus cover 100 may be disposable, cleanable, disinfectable, re-usable, and/or sterilizeable [0023]; At 1112, the cover 100 is installed on the ultrasound apparatus 102. As described herein, this includes physically contacting the acoustically transmissive adhesive 108 with the acoustic window 106 of the ultrasound apparatus 102, where the acoustically transmissive adhesive 108 holds the cover 100 in place [0054]; [0024], [0031]-[0034] discloses guiding the needle with respect to the needle shield/cover 100).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Burnside to include a needle shield coupled to the probe head, the needle shield formed of a resilient material that is transparent to acoustic energy and resistant to penetrations from the needle, as taught by Gubbini. Doing so would allow for the ultrasound apparatus cover 100 may provide a sonographer or other user of the ultrasound apparatus 102 a quick way of rendering the side 106 of the ultrasound apparatus 102 sterile, as suggested by Gubbini ([0023]).
Regarding claim 19, modified Burnside teaches the method of claim 11, as discussed above. Burnside, however, does not teach a needle shield coupled to the probe head, the needle shield formed of a resilient material that is transparent to acoustic energy and resistant to penetrations from the needle.
Gubbini is considered analogous to the instant application as “Ultrasound apparatus cover” is disclosed (title). Gubbini teaches a needle shield (100; fig. 3 ) coupled to the probe head (a probe head 216 [0028]; fig. 3; cover 100 attached to probe head 216 as shown in fig. 3), the needle shield formed of a resilient material (The ultrasound apparatus cover 100 is generally rigid and pre-formed (e.g., thermo, injection mold, or otherwise formed) so that the first side geometrically conforms to a shape of at least a portion of the ultrasound apparatus 102 that includes the acoustic window/lens 106 [0021]) that is transparent to acoustic energy and resistant to penetrations from the needle (The ultrasound apparatus cover 100 may be disposable, cleanable, disinfectable, re-usable, and/or sterilizeable [0023]; At 1112, the cover 100 is installed on the ultrasound apparatus 102. As described herein, this includes physically contacting the acoustically transmissive adhesive 108 with the acoustic window 106 of the ultrasound apparatus 102, where the acoustically transmissive adhesive 108 holds the cover 100 in place [0054]; [0024], [0031]-[0034] discloses guiding the needle with respect to the needle shield/cover 100).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Burnside to include a needle shield coupled to the probe head, the needle shield formed of a resilient material that is transparent to acoustic energy and resistant to penetrations from the needle, as taught by Gubbini. Doing so would allow for the ultrasound apparatus cover 100 may provide a sonographer or other user of the ultrasound apparatus 102 a quick way of rendering the side 106 of the ultrasound apparatus 102 sterile, as suggested by Gubbini ([0023]).
Claims 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Burnside et al. (US 10231753 B2, of record, hereinafter "Burnside") in view of Xia et al. (US 20210307838A1, hereinafter "Xia") and Pinkovich et al (US 20210077061 A1).
Regarding claim 21, modified Burnside teaches the ultrasound system of claim 1, as discussed above. Burnside, however, does not teach wherein the increasingly cautionary alerts include visual alerts on the display for observation by the clinician while the needle is advanced by the clinician to the blood vessel under the probe head.
Pinkovich is considered analogous to the instant application as “Method and system for analyzing ultrasound scenes to provide needle guidance and warnings” is disclosed (title). Pinkovich teaches wherein the increasingly cautionary alerts include visual alerts on the display for observation by the clinician while the needle is advanced by the clinician to the blood vessel under the probe head (ultrasound probe 104 [0020]the display and warning processor 170 of the signal processor 132 may determine whether the distance between a head of a needle and a nerve or a vessel is less than a threshold. The threshold may be a defined distance corresponding with a needle getting too close to the nerve or vessel. The threshold value may be user-defined or a default value. In various embodiments, the threshold may include multiple thresholds corresponding with different levels of closeness, such as not close, somewhat close, and too close. The process 300 may proceed to step 314 if the distance is less than the defined threshold or may proceed to step 316 if the distance is not less than the defined threshold [0055]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Burnside to include wherein the increasingly cautionary alerts include visual alerts on the display for observation by the clinician while the needle is advanced by the clinician to the blood vessel under the probe head, as taught by Pinkovich. Doing so would facilitate navigation of the needle during a procedure.
Regarding claim 22, modified Burnside teaches the ultrasound system of claim 21, as discussed above. Burnside, however, does not teach wherein the increasingly cautionary alerts include: a first alert in response to the distance being within a first threshold; a second alert in response to the distance being within a second threshold less than the first threshold; and a third alert in response to the distance being within a third threshold less than the second threshold for observation by the clinician while the needle is advanced by the clinician to the blood vessel under the probe head.
Pinkovich is considered analogous to the instant application as “Method and system for analyzing ultrasound scenes to provide needle guidance and warnings” is disclosed (title). Pinkovich teaches:
wherein the increasingly cautionary alerts include: a first alert in response to the distance being within a first threshold; a second alert in response to the distance being within a second threshold less than the first threshold; and a third alert in response to the distance being within a third threshold less than the second threshold for observation by the clinician while the needle is advanced by the clinician to the blood vessel under the probe head (the display and warning processor 170 may determine a distance between a needle and a vessel and may provide an alert if the needle is getting too close to the vessel. The alert may be a visual warning, audio warning, and/or physical warning. The visual warning may be a visual message presented at the display system 134, a change in the appearance of the highlighting, or any suitable visual warning. For example, the color of the highlighting (e.g., red for too close, yellow for getting close, green for not close, etc.) or the type of highlighting (e.g., colorized structure, structure outlined with solid lines, structure outlined with dashed lines, etc.) may correspond with a level of proximity between highlighted structures. [0040]; the three colors are the three thresholds as claimed).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Burnside to include a first alert in response to the distance being within a first threshold; a second alert in response to the distance being within a second threshold less than the first threshold; and a third alert in response to the distance being within a third threshold less than the second threshold for observation by the clinician while the needle is advanced by the clinician to the blood vessel under the probe head, as taught by Pinkovich. Doing so would facilitate navigation of the needle during a procedure.
Regarding claim 23, modified Burnside teaches the ultrasound system of claim 22, as discussed above. Burnside, however, does not teach wherein the first alert, the second alert, and the third alert are in different colors for the increasingly cautionary alerts.
Pinkovich teaches: wherein the first alert, the second alert, and the third alert are in different colors for the increasingly cautionary alerts (the display and warning processor 170 may determine a distance between a needle and a vessel and may provide an alert if the needle is getting too close to the vessel. The alert may be a visual warning, audio warning, and/or physical warning. The visual warning may be a visual message presented at the display system 134, a change in the appearance of the highlighting, or any suitable visual warning. For example, the color of the highlighting (e.g., red for too close, yellow for getting close, green for not close, etc.) or the type of highlighting (e.g., colorized structure, structure outlined with solid lines, structure outlined with dashed lines, etc.) may correspond with a level of proximity between highlighted structures. [0040]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Burnside to wherein the first alert, the second alert, and the third alert are in different colors for the increasingly cautionary alerts, as taught by Pinkovich. Doing so would facilitate navigation of the needle during a procedure.
Regarding claim 24, modified Burnside teaches the ultrasound system of claim 22, as discussed above. Burnside, however, the increasingly cautionary alerts include visual alerts on the display for observation by the clinician while the needle is advanced by the clinician to the blood vessel under the probe head.
Pinkovich teaches the increasingly cautionary alerts include visual alerts on the display for observation by the clinician while the needle is advanced by the clinician to the blood vessel under the probe head. (the display and warning processor 170 may determine a distance between a needle and a vessel and may provide an alert if the needle is getting too close to the vessel. The alert may be a visual warning, audio warning, and/or physical warning. The visual warning may be a visual message presented at the display system 134, a change in the appearance of the highlighting, or any suitable visual warning. For example, the color of the highlighting (e.g., red for too close, yellow for getting close, green for not close, etc.) or the type of highlighting (e.g., colorized structure, structure outlined with solid lines, structure outlined with dashed lines, etc.) may correspond with a level of proximity between highlighted structures. [0040]; The ultrasound probe 104 may comprise a two dimensional (2D) array of piezoelectric elements. The ultrasound probe 104 may comprise a group of transmit transducer elements 106 and a group of receive transducer elements 108, that normally constitute the same elements. In certain embodiment, the ultrasound probe 104 may be operable to acquire ultrasound image data covering at least a substantial portion of an anatomy, such as the heart, a blood vessel, or any suitable anatomical structure [0020]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Burnside to include wherein the increasingly cautionary alerts include visual alerts on the display for observation by the clinician while the needle is advanced by the clinician to the blood vessel under the probe head., as taught by Pinkovich. Doing so would facilitate navigation of the needle during a procedure.
Regarding claim 25, modified Burnside teaches the ultrasound system of claim 24, as discussed above. Burnside, however, does not teach wherein the increasingly cautionary alerts include: a first alert in response to the distance being within a first threshold; a second alert in response to the distance being within a second threshold less than the first threshold; Anda third alert in response to the distance being within a third threshold less than the second threshold for observation by the clinician while the needle is advanced by the clinician to the blood vessel under the probe head.
Pinkovich is considered analogous to the instant application as “Method and system for analyzing ultrasound scenes to provide needle guidance and warnings” is disclosed (title). Pinkovich teaches: a first alert in response to the distance being within a first threshold; a second alert in response to the distance being within a second threshold less than the first threshold; Anda third alert in response to the distance being within a third threshold less than the second threshold for observation by the clinician while the needle is advanced by the clinician to the blood vessel under the probe head (the display and warning processor 170 may determine a distance between a needle and a vessel and may provide an alert if the needle is getting too close to the vessel. The alert may be a visual warning, audio warning, and/or physical warning. The visual warning may be a visual message presented at the display system 134, a change in the appearance of the highlighting, or any suitable visual warning. For example, the color of the highlighting (e.g., red for too close, yellow for getting close, green for not close, etc.) or the type of highlighting (e.g., colorized structure, structure outlined with solid lines, structure outlined with dashed lines, etc.) may correspond with a level of proximity between highlighted structures. [0040]; the three colors are the three thresholds as claimed).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Burnside to include a first alert in response to the distance being within a first threshold; a second alert in response to the distance being within a second threshold less than the first threshold; and a third alert in response to the distance being within a third threshold less than the second threshold for observation by the clinician while the needle is advanced by the clinician to the blood vessel under the probe head., as taught by Pinkovich. Doing so would facilitate navigation of the needle during a procedure.
Regarding claim 26, modified Burnside teaches the method of claim 25, as discussed above. Burnside, however, does not teach wherein the first alert, the second alert, and the third alert are in different colors for the increasingly cautionary alerts.
Pinkovich, however, teaches wherein the first alert, the second alert, and the third alert are in different colors for the increasingly cautionary alerts to include (the display and warning processor 170 may determine a distance between a needle and a vessel and may provide an alert if the needle is getting too close to the vessel. The alert may be a visual warning, audio warning, and/or physical warning. The visual warning may be a visual message presented at the display system 134, a change in the appearance of the highlighting, or any suitable visual warning. For example, the color of the highlighting (e.g., red for too close, yellow for getting close, green for not close, etc.) or the type of highlighting (e.g., colorized structure, structure outlined with solid lines, structure outlined with dashed lines, etc.) may correspond with a level of proximity between highlighted structures. [0040]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Burnside to include wherein the first alert, the second alert, and the third alert are in different colors for the increasingly cautionary alerts, as taught by Pinkovich. Doing so would facilitate navigation of the needle during a procedure.
Response to Arguments
Applicant's arguments filed 01/30/2026 have been fully considered but they are no persuasive.
Regarding the 35 USC 103 rejection of claims 1 and 11, applicant argues that Xia does not teach the limitation regarding “generating increasingly cautionary alerts within predetermined thresholds of the distance between the distal tip of the needle and the ultrasound probe, the increasingly cautionary alerts configured to protect against breaching the probe head with the distal tip of the needle while the needle is advanced by a clinician to the blood vessel under the probe head”, describes a single alert which occurs when a distance is smaller than a preset threshold. A single alert cannot properly be interpreted as increasingly cautionary alerts. Further, Xia describes an alert that occurs when the offset distance of the needle and the ultrasound image or the target area is smaller than a present threshold. Neither the ultrasound image nor the target area can properly be interpreted as the ultrasound probe itself”. In response, the examiner respectfully disagrees, paragraph [0103] of Xia discloses that the location of both the ultrasound probe and ultrasound needle, as well as the ultrasound are tracked in real time, and these coordinates are then used to generate alerts in paragraph [0038]. The tracking module with all of the elements are shown in Figure 7. The user can both visually see the path of the needle in the image, and use the multiple coordinate system as disclosed in [0054], and receive alerts if it is out of the calculated threshold as disclosed in [0038]. Accordingly, this argument is not persuasive and the rejection is maintained. A
Applicant’s arguments on page 7 are premised upon the assertion 35 USC 103 rejection of the remaining dependent claim is allowable for the same reasons as stated above for claims 1 and 11. The examiner respectfully disagrees for the reasons stated above.
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.
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/N.B./Examiner, Art Unit 3793
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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