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
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, 5, 8-16, 21-22, 24-26, & 28 are rejected under 35 U.S.C. 103 as being unpatentable over Singanamalli et al (US 20210068793 A1; hereinafter referred to as Singanamalli) in view of Puleo et al (US20200069976A1; hereinafter referred to as Puleo).
Regarding Claim 1, Singanamalli discloses a neuromodulation delivery system ("a neuromodulation delivery system is provided.” [0004]) comprising:
an energy application device (“The system includes an energy application device configured to deliver neuromodulating energy to a region of interest in a subject." [0004]);
and an alignment controller, wherein the alignment controller is implemented on a processor and ("controller configured to control the energy application device to acquire image data" [0006], “The controller 16 includes a processor 30 for controlling the device” [0036]), wherein the alignment controller is configured to perform acts comprising:
receiving image data from the energy application device ("controller configured to control the energy application device to acquire image data" [0006]),
wherein the image data comprises images of internal tissue based on a current position and orientation of the energy application device relative to a subject ("identify the region of interest within the image data; control application of the neuromodulating energy via the energy application device to the identified region of interest to deliver a dose of the neuromodulating energy thereto [based on the position and orientation]" [0004], “The processor 30 may be configured to operate a neural network and identify the region of interest using a relatively simple interface while providing guidance to move the energy application device 12 to a correct treatment position.” [0037]);
determining an alignment score of the energy application device with respect to an anatomic target based on the image data, wherein the alignment score indicates a metric indicating overlap between a therapy zone and the anatomic target, wherein the therapy zone comprises a region within the image data that a therapy transducer of the energy application device is capable of delivering therapy ("the system waits for the target anatomy (in this case liver) to appear in the field of view before delivering the therapy. The identified probe placement is not suited for delivering the therapy and therefore the status indicates “aligning.” In FIG. 13, the therapy or neuromodulating energy dose is delivered upon determination that the anatomy of interest aligns with the anatomy in the field of view as identified by the neural network. The status indicates “delivering" [confirmation for aligning] and the therapy beam is visualized in the ultrasound image." [0061], "the identification of the organ or region of interest within the organ may be based on reaching a probabilistic threshold of identification based on the output of the neural network. In one example, the threshold may be at least 95%, at least 97%, or at least 99%." [0062]);
comparing the alignment score to one or more predetermined threshold ranges corresponding to delivery of a target therapy dosage to the subject (“the system waits for the target anatomy (in this case liver) to appear in the field of view before delivering the therapy. The identified probe placement is not suited for delivering the therapy and therefore the status indicates “aligning.” In FIG. 13, the therapy or neuromodulating energy dose is delivered upon determination that the anatomy of interest aligns with the anatomy in the field of view as identified by the neural network. The status indicates “delivering,” and the therapy beam is visualized in the ultrasound image” [0061])
and providing a control signal to maintain or change one or both of the current position or orientation of the energy application device in response to the alignment score ("and adjust application of the neuromodulating energy via the energy application device based on the changed location of the region of interest to continue the delivering of the dose of the neuromodulating energy to treat the subject." [0004], "The beam controller may receive instructions from the processor 30 to cause changes in focusing and/or steering of the energy beam. The system 10 may be responsive to position sensor/s 38 and/or contact sensor/s 39 that provide feedback on the energy application device 12. The beam controller 37 may include a motor to facilitate steering of one or more articulating portions of the energy application device 12....the probe is shaped more like a conventional imaging probe, is held by a motorized fixture, and is moved along the skin in up to 6 degrees of freedom in a similar manner to freehand scanning. Changing angles corresponds to 3 degrees of freedom, and corresponds to steering the beam in 3D space. Changing the position corresponds to the other 3 degrees of freedom, and is comprised of XY movement to slide along the surface of the body, or Z movement corresponds to adjusting the depth of focus or contact force. It is contemplated that the system 10 may include features to permit position, steering, and/or focus adjustments to facilitate the techniques disclosed herein." [0038]).
wherein the change comprises dynamically adjusting a therapy dosage delivery time based on a change in the alignment score over time relative to the predetermined threshold ranges (“The disclosed techniques provide autonomous delivery of neuromodulating energy that accounts for and dynamically adjusts one or more parameters of the delivery based on changes in a location of a desired target of the energy (e.g., a region of interest) during the course of energy delivery such that the energy delivery need not be interrupted.” [0025], “the system 10 may use the image data and the determined position of the region of interest 44 relative to the focal zone 48 to account for dosage delivery over time. For example, in an embodiment, the energy application device 12 may minimally adjust steering and/or focusing of energy delivery over the course of movement of the region of interest while adjusting other parameters. Based on identified movement of the region of interest 44 outside of the focal zone 48, the system 10 may calculate a total dose delivery. Accordingly, the movement may cause the system 10 to extend the period of dose delivery so that the total dose delivered directly to the region of interest 44 is within desired parameters and to account for periods when the region of interest 44 is outside of the focal zone 48 during delivery of energy. Further, the system 10 may also account for total delivery to areas outside of the region of interest 44 and adjust steering and/or focusing when energy applied outside of the region of interest 44 reaches a threshold.” [0054])
Singanamalli does not specifically disclose that the alignment score indicates a quantitative metric indicating overlap between a therapy zone and the anatomic target,.
However, in a similar field of endeavor, Puleo teaches techniques for facilitating personalized neuromodulation treatment protocols [Abstract]
Puleo also teaches that the alignment score indicates a quantitative metric indicating overlap between a therapy zone and the anatomic target (“When the patient 70 or other caregiver initiates subsequent neuromodulation treatments as part of the treatment protocol, the energy application device 12 (either the same energy application device 12 used to acquire the predetermined treatment position 46 or a different energy application device 12 configured to operate in a similar manner) is positioned on the patient and a determination is made if the position aligns with (is the same as or overlaps significantly with) the predetermined treatment position 46.” [0065], “the off-target energy application device 12 is partially within but not entirely within a region associated with a predetermined treatment position 46 while the on-target energy application device 12 is entirely within a region associated with a predetermined treatment position 46. The system 10 may be configured to permit a certain level of tolerance or deviation from a predetermined treatment position 46 and still be considered on-target. In one embodiment, the energy application device 12 is considered to be off-target based on a degree of mismatch with the acquired image associated with the predetermined treatment position 46. For example, less than a 90% match per image registration may be indicative of an off-target position while a 90% or greater match may be on-target.” [0069], quantitatively the difference in image mismatch (alignment) between the energy application device (therapy zone) and the predetermined treatment position (anatomic target) is tracked)
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 Singanamalli as outlined above with the alignment score indicates a quantitative metric indicating overlap between a therapy zone and the anatomic target as taught by Puleo, because Simple feedback of the device position permits the patient to find the predetermined treatment position without interpreting an image that may be difficult for an untrained operator to resolve [0073].
Regarding Claim 3, Singanamalli discloses that a position of the energy application device comprises an external position of the energy application device relative to the subject, a position of an imaging transducer, a therapy transducer, or both within the energy application device ("The system 10 may be responsive to position sensor/s 38 and/or contact sensor/s 39 that provide feedback on the energy application device 12.", "That is, the energy application device 12 is positioned roughly at the correct position (i.e., the treatment position 46), and fine steering/focusing is accomplished in real-time. In cases where the region of interest 44 moves outside of the zone of the potential treatment area 70, energy delivery is suspended via the controller 16. An alarm or notification may be provided. The system 10 may be configured to wait to determine (based on image data acquired from the imaging transducer 68) if the region of interest 44 returns to a position within the potential treatment area 70 before resuming." [0050]).
Regarding Claim 5, Singanamalli discloses that localizing the image data comprises comparing the image data with subject specific data, population specific data, or both ("the image data being representative of an internal tissue of the subject; identify the region of interest based on the image data using a neural network trained on image data of respective internal tissues of a population of subjects" [0006]).
Regarding Claim 8, Singanamalli discloses that the energy application device comprises a position sensor configured to generate position data over time, and to track position of the energy application device relative to the anatomic target over a subject respiration cycle ("The beam controller may receive instructions from the processor 30 to cause changes in focusing and/or steering of the energy beam. The system 10 may be responsive to position sensor/s 38 and/or contact sensor/s 39 that provide feedback on the energy application device 12" [0038], “the beam of the neuromodulating energy may be dynamically adjusted to account for movement of an organ during breathing.” [Abstract]).
Regarding Claim 9, Singanamalli discloses that the control signal is sent to an automation controller within the energy application device, wherein the automation controller is implemented on a processor ("controller configured to control the energy application device to acquire image data" [0006], “The controller 16 includes a processor 30 for controlling the device” [0036]),
and wherein the automation controller electronically adjusts the energy application device position, orientation, or both in response to the control signal ("The beam controller 37 may also control or one or more articulating portions of the energy application device 12 to reposition the transducer. The beam controller may receive instructions from the processor 30 to cause changes in focusing and/or steering of the energy beam...the probe is shaped more like a conventional imaging probe, is held by a motorized fixture, and is moved along the skin in up to 6 degrees of freedom in a similar manner to freehand scanning. Changing angles corresponds to 3 degrees of freedom, and corresponds to steering the beam in 3D space. Changing the position corresponds to the other 3 degrees of freedom, and is comprised of XY movement to slide along the surface of the body, or Z movement corresponds to adjusting the depth of focus or contact force. It is contemplated that the system 10 may include features to permit position, steering, and/or focus adjustments" [0038]).
Regarding Claim 10, Singanamalli discloses that wherein the control signal comprises a directional signal indicating a direction to move or orient the energy application device to meet a threshold range ("If the region of interest is not determined to be within the potential treatment area 70 after a predetermined period of time has elapsed, an indication may be provided to move the energy application device 12 to a new treatment position 46. In this manner, the energy application device is only moved upon determining that the region of interest 44 is not within the potential treatment area 70, which reduces operator burden and potential for incorrect positioning and repositioning of the energy application device 12. Further, even slightly incorrect positioning of the energy application device 12 may be corrected using the neural network or other techniques for identifying the region of interest 44 within the potential treatment zone 70." [0050], "the identification of the organ or region of interest within the organ may be based on reaching a probabilistic threshold of identification based on the output of the neural network. In one example, the threshold may be at least 95%, at least 97%, or at least 99%." [0062]).
wherein the threshold range corresponds to a set threshold for effective therapy dosage (“Further, even slightly incorrect positioning of the energy application device 12 may be corrected using the neural network or other techniques for identifying the region of interest 44 within the potential treatment zone 70." [0050], "the identification of the organ or region of interest within the organ may be based on reaching a probabilistic threshold of identification based on the output of the neural network. In one example, the threshold may be at least 95%, at least 97%, or at least 99%." [0062]).
Regarding Claim 11, Singanamalli discloses that the directional signal comprises degree of freedom (DOF) data and indicates directional movement in a two-dimensional plane relative to the subject ("the probe is shaped more like a conventional imaging probe, is held by a motorized fixture, and is moved along the skin in up to 6 degrees of freedom in a similar manner to freehand scanning. Changing angles corresponds to 3 degrees of freedom, and corresponds to steering the beam in 3D space. Changing the position corresponds to the other 3 degrees of freedom, and is comprised of XY movement to slide along the surface of the body, or Z movement corresponds to adjusting the depth of focus or contact force." [0038]).
Regarding Claim 12, Singanamalli discloses that the image data comprises two-dimensional plane data, three-dimensional volume data, Doppler data, or any combination thereof ("It should be understood that the image data used to guide the focus location may be a volume or a plane." [0042]).
Regarding Claim 13, Singanamalli discloses that the image data comprises time series data ("the updated image data may be assessed as being characteristic of a particular type of movement. For example, a rhythmic or periodic movement of the tissue 43 and/or the region of interest towards the transducer 68 and then away from the transducer 68 that occurs over a time period (e.g., 1-5 seconds) may be characteristic of breathing. The system may predict future breaths and create a model of predicted movement of the region of interest 44 over time to align energy delivery at a particular time with a predicted position or positions of the region of interest 44 during the breath" [0053]).
Regarding Claim 14, Singanamalli discloses a method ("a method of delivery of neuromodulating energy is provided. " [0005]) comprising:
receiving, via a processor (“The controller 16 includes a processor 30 for controlling the device.” [0036]),
image data from a neuromodulation delivery system at a current position and orientation relative to a subject, wherein the image data comprises images of internal tissue of the subject based at the current position and orientation ("identify the region of interest within the image data; control application of the neuromodulating energy via the energy application device to the identified region of interest to deliver a dose of the neuromodulating energy thereto" [0004], The system also includes a controller configured to control the energy application device to acquire image data" [0006);
determining, via the processor, an alignment score of the energy application device to an anatomic target based on the image data wherein the alignment score indicates a metric indicating overlap between a therapy zone and the anatomic target, wherein the therapy zone comprises a region within the image data that a therapy transducer of the energy application device is capable of delivering therapy ("the system waits for the target anatomy (in this case liver) to appear in the field of view before delivering the therapy. The identified probe placement is not suited for delivering the therapy and therefore the status indicates “aligning.” In FIG. 13, the therapy or neuromodulating energy dose is delivered upon determination that the anatomy of interest aligns with the anatomy in the field of view as identified by the neural network. The status indicates “delivering" [confirmation for aligning] and the therapy beam is visualized in the ultrasound image." [0061], "the identification of the organ or region of interest within the organ may be based on reaching a probabilistic threshold of identification based on the output of the neural network. In one example, the threshold may be at least 95%, at least 97%, or at least 99%." [0062]);
comparing the alignment score to one or more predetermined threshold ranges corresponding to delivery of a target therapy dosage to the subject (“The disclosed techniques provide autonomous delivery of neuromodulating energy that accounts for and dynamically adjusts one or more parameters of the delivery based on changes in a location of a desired target of the energy (e.g., a region of interest) during the course of energy delivery such that the energy delivery need not be interrupted.” [0025], “the system 10 may use the image data and the determined position of the region of interest 44 relative to the focal zone 48 to account for dosage delivery over time. For example, in an embodiment, the energy application device 12 may minimally adjust steering and/or focusing of energy delivery over the course of movement of the region of interest while adjusting other parameters. Based on identified movement of the region of interest 44 outside of the focal zone 48, the system 10 may calculate a total dose delivery. Accordingly, the movement may cause the system 10 to extend the period of dose delivery so that the total dose delivered directly to the region of interest 44 is within desired parameters and to account for periods when the region of interest 44 is outside of the focal zone 48 during delivery of energy. Further, the system 10 may also account for total delivery to areas outside of the region of interest 44 and adjust steering and/or focusing when energy applied outside of the region of interest 44 reaches a threshold.” [0054])
and providing a control signal to maintain or change one or both of the current position or orientation of the energy application device in response to the alignment score ("and adjust application of the neuromodulating energy via the energy application device based on the changed location of the region of interest to continue the delivering of the dose of the neuromodulating energy to treat the subject." [0004], "The beam controller may receive instructions from the processor 30 to cause changes in focusing and/or steering of the energy beam. The system 10 may be responsive to position sensor/s 38 and/or contact sensor/s 39 that provide feedback on the energy application device 12. The beam controller 37 may include a motor to facilitate steering of one or more articulating portions of the energy application device 12....the probe is shaped more like a conventional imaging probe, is held by a motorized fixture, and is moved along the skin in up to 6 degrees of freedom in a similar manner to freehand scanning. Changing angles corresponds to 3 degrees of freedom, and corresponds to steering the beam in 3D space. Changing the position corresponds to the other 3 degrees of freedom, and is comprised of XY movement to slide along the surface of the body, or Z movement corresponds to adjusting the depth of focus or contact force. It is contemplated that the system 10 may include features to permit position, steering, and/or focus adjustments to facilitate the techniques disclosed herein." [0038]).
wherein the change comprises dynamically adjusting a therapy dosage delivery time based on a change in the alignment score over time relative to the predetermined threshold ranges (“The disclosed techniques provide autonomous delivery of neuromodulating energy that accounts for and dynamically adjusts one or more parameters of the delivery based on changes in a location of a desired target of the energy (e.g., a region of interest) during the course of energy delivery such that the energy delivery need not be interrupted.” [0025], “the system 10 may use the image data and the determined position of the region of interest 44 relative to the focal zone 48 to account for dosage delivery over time. For example, in an embodiment, the energy application device 12 may minimally adjust steering and/or focusing of energy delivery over the course of movement of the region of interest while adjusting other parameters. Based on identified movement of the region of interest 44 outside of the focal zone 48, the system 10 may calculate a total dose delivery. Accordingly, the movement may cause the system 10 to extend the period of dose delivery so that the total dose delivered directly to the region of interest 44 is within desired parameters and to account for periods when the region of interest 44 is outside of the focal zone 48 during delivery of energy. Further, the system 10 may also account for total delivery to areas outside of the region of interest 44 and adjust steering and/or focusing when energy applied outside of the region of interest 44 reaches a threshold.” [0054])
Singanamalli does not specifically disclose that the alignment score indicates a quantitative metric indicating overlap between a therapy zone and the anatomic target.
However, in a similar field of endeavor, Puleo teaches techniques for facilitating personalized neuromodulation treatment protocols [Abstract]
Puleo also teaches that the alignment score indicates a quantitative metric indicating overlap between a therapy zone and the anatomic target (“When the patient 70 or other caregiver initiates subsequent neuromodulation treatments as part of the treatment protocol, the energy application device 12 (either the same energy application device 12 used to acquire the predetermined treatment position 46 or a different energy application device 12 configured to operate in a similar manner) is positioned on the patient and a determination is made if the position aligns with (is the same as or overlaps significantly with) the predetermined treatment position 46.” [0065], “the off-target energy application device 12 is partially within but not entirely within a region associated with a predetermined treatment position 46 while the on-target energy application device 12 is entirely within a region associated with a predetermined treatment position 46. The system 10 may be configured to permit a certain level of tolerance or deviation from a predetermined treatment position 46 and still be considered on-target. In one embodiment, the energy application device 12 is considered to be off-target based on a degree of mismatch with the acquired image associated with the predetermined treatment position 46. For example, less than a 90% match per image registration may be indicative of an off-target position while a 90% or greater match may be on-target.” [0069], quantitatively the difference in image mismatch (alignment) between the energy application device (therapy zone) and the predetermined treatment position (anatomic target) is tracked)
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 Singanamalli as outlined above with the alignment score indicates a quantitative metric indicating overlap between a therapy zone and the anatomic target as taught by Puleo, because simple feedback of the device position permits the patient to find the predetermined treatment position without interpreting an image that may be difficult for an untrained operator to resolve [0073].
Regarding Claim 15, Singanamalli discloses that the method further includes receiving time-series image data at an additional time, and determining a predicted therapy dose session time based on the alignment score over time corresponding to the time-series image data at the additional time (“the updated image data may be assessed as being characteristic of a particular type of movement… The system may predict future breaths and create a model of predicted movement of the region of interest 44 over time to align energy delivery at a particular time with a predicted position or positions of the region of interest 44 during the breath.” [0053], "the therapy or neuromodulating energy dose is delivered upon determination that the anatomy of interest aligns with the anatomy in the field of view as identified by the neural network. The status indicates “delivering" [confirmation for aligning] and the therapy beam is visualized in the ultrasound image." [0061]).
Regarding Claim 16, Singanamalli discloses that the image data comprises time-series image data over a respiration cycle of the subject, wherein the time-series image data is used to monitor movement of internal anatomy of the subject relative to the current position and orientation of the energy application device over the respiration cycle ("the updated image data may be assessed as being characteristic of a particular type of movement. For example, a rhythmic or periodic movement of the tissue 43 and/or the region of interest towards the transducer 68 and then away from the transducer 68 that occurs over a time period (e.g., 1-5 seconds) may be characteristic of breathing. The system may predict future breaths and create a model of predicted movement of the region of interest 44 over time to align energy delivery at a particular time with a predicted position or positions of the region of interest 44 during the breath." [0053]).
Regarding Claim 21, Singanamalli discloses that the alignment controller is configured to send the control signal to electronically steer and/or focus the energy application device to a desired position and orientation ("The system may include a beam controller 37 that may control a focus location of the energy beam of the energy application device 12 by controlling one or both of steering and/or focusing of the energy application device 12. The beam controller 37 may also control or one or more articulating portions of the energy application device 12 to reposition the transducer. The beam controller may receive instructions from the processor 30 to cause changes in focusing and/or steering of the energy beam." [0038]).
Regarding Claim 22, Singanamalli discloses that the alignment controller is configured to receive a plurality of sensor data, wherein the plurality of sensor data is used to monitor movement of internal anatomy of the subject relative to the current position and orientation of the energy application device over a respiration cycle ("The system 10 may be responsive to position sensor/s 38 and/or contact sensor/s 39 that provide feedback on the energy application device 12" [0038], "the updated image data may be assessed as being characteristic of a particular type of movement. For example, a rhythmic or periodic movement of the tissue 43 and/or the region of interest towards the transducer 68 and then away from the transducer 68 that occurs over a time period (e.g., 1-5 seconds) may be characteristic of breathing. The system may predict future breaths and create a model of predicted movement of the region of interest 44 over time to align energy delivery at a particular time with a predicted position or positions of the region of interest 44 during the breath.", “the beam of the neuromodulating energy may be dynamically adjusted to account for movement of an organ during breathing.” [Abstract]).
Regarding Claim 24, Singanamalli discloses that an electronic device is configured to display a determined on-target percent alignment is within a threshold on-target percent alignment ("the therapy or neuromodulating energy dose is delivered upon determination that the anatomy of interest aligns with the anatomy in the field of view as identified by the neural network.The status indicates “delivering" [confirmation for alinging] and the therapy beam is visualized in the ultrasound image." [0061] "the identification of the organ or region of interest within the organ may be based on reaching a probabilistic threshold of identification based on the output of the neural network. In one example, the threshold may be at least 95%, at least 97%, or at least 99%." [0062], if the neural network determines that the identification has not reached the percentage threshold it will display aligning and once it does meet the percentage threshold it will display delivering).
Regarding Claim 25, Singanamalli discloses receiving time-series image data and position data of the anatomic target relative to the therapy zone during a respiration cycle of the subject (”the updated image data may be assessed as being characteristic of a particular type of movement. For example, a rhythmic or periodic movement of the tissue 43 and/or the region of interest towards the transducer 68 and then away from the transducer 68 that occurs over a time period (e.g., 1-5 seconds) may be characteristic of breathing.” [0053];
determining a trajectory of the anatomic target based on the time-series image data and the position data, wherein the trajectory is indicative of a projected path of the anatomic target over time relative to the subject during the respiration cycle; and generating the alignment score based on the trajectory (“The system may predict future breaths and create a model of predicted movement of the region of interest 44 over time to align energy delivery at a particular time with a predicted position or positions of the region of interest 44 during the breath. In an additional or alternative embodiment, the system 10 may identify pauses or ends of breaths within the acquired image data and align energy delivery to time periods in which the region of interest is relatively still while the subject pauses between breaths.” [0053])
Regarding Claim 26, Singanamalli discloses the anatomic target comprises a portal vein (“The region of interest 44 and/or the target tissue 43 may include various anatomical features or structures to facilitate automatic identification, e.g., via a neural network, as provided herein. For example, the organ may have characteristic edges 50 in a particular shape, may have capillaries or smaller blood vessels 52 as well as internal nerve structures 54 that enter the tissue 43… Other identifying features may be bifurcations in blood vessels, entry/exit points of arteries and veins into organs (“porta”, “hilus”, “hilum”, “fissure”, “indendation”, “duct”, etc.).” [0045]).
Regarding Claim 28, Singanamalli teaches all limitations noted above except the alignment controller is further configured to perform acts comprising: dynamically updating a display with the adjusted therapy dosage delivery time.
However, in a similar field of endeavor, Puleo teaches the alignment controller is further configured to perform acts comprising: dynamically updating a display with the adjusted therapy dosage delivery time (“FIG. 25 shows an embodiment in which the controller 16 provides an indicator via the display 36 relating to the total dose. For example, a shape may fill in as the dose is accumulating. Further, the display 36 may provide a user interface that indicates that the energy application device 12 is correctly positioned to provide the dose to the region of interest 44.” [0088]).
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 Singanamalli as outlined above with the alignment controller is further configured to perform acts comprising: dynamically updating a display with the adjusted therapy dosage delivery time as taught by Puleo, because simple feedback of the device position permits the patient to find the predetermined treatment position without interpreting an image that may be difficult for an untrained operator to resolve [0073].
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Singanamalli in view of Puleo as applied to Claim 1, and further in view of Desmet et al (WO2022178631A1; hereinafter referred to as Desmet).
Regarding Claim 6, Singanamalli in view of Puleo discloses all limitations noted above except that the alignment score comprises a cumulative percent alignment score comprising an average of a plurality of alignment scores over time.
However, in the similar field of tracking ultrasonic probe alignment, Desmet teaches automated machine learning models used to process an image resulting from a user positioning an imaging device at various imaging device positions relative to a human, to determine whether the generated image corresponds to a predefined view required for the analysis of the organ features [Abstract]
Desmet also teaches that the alignment score comprises a cumulative percent alignment score comprising an average of a plurality of alignment scores over time ("The method comprises assigning a probe score based on a position of an imaging probe being manipulated by the user, compared to a previously determined valid probe position for a given view of the anatomical region. " [0006], "comprises one or more displays for displaying the generated image as the user moves the imaging probe, and for displaying a probe score and an image score, the probe score being indicative of a positional similarity between the position of the probe and (a) position(s) previously determined as valid," [0037], "The calculated probe distance can be normalized, and a probe score 220, such as a percentage from 0-100% can be provided for display on the display screen." [0056]).
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 Singanamalli in view of Puleo as outlined above with the alignment score comprises a cumulative percent alignment score comprising an average of a plurality of alignment scores over time as taught by Desmet, because it would provide improved feedback when assessing whether an image captured is suitable for anatomical analysis [0005].
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Singanamalli in view of Puleo as applied to Claim 26, and further in view of Gertner (US20220202483A1).
Regarding Claim 27, Singanamalli in view of Puleo discloses all limitations noted above except that the alignment controller is further configured to perform acts comprising:tracking a motion of the portal vein in the image data over time.
However, in a similar field of endeavor, Gertner teaches a system for treatment includes a focused ultrasound energy source for placement outside a patient, wherein the focused ultrasound energy source is configured to deliver ultrasound energy towards a blood vessel with a surrounding nerve that is a part of an autonomic nervous system inside the patient [0018].
Gertner also teaches the alignment controller is further configured to perform acts comprising: tracking a motion of the portal vein in the image data over time (“the focused ultrasound energy source is configured to track the movement of the nerve by tracking a movement of the blood vessel next to the nerve.” [0070] “For example, nerves surrounding the… portal vein… can be affected by the energy in a specific manner so as to create changes in the autonomic responses of the blood vessels themselves or organs related to the blood vessels, the nerves running through and along the vessels to the organs.” [0289], “The movement mechanism can operate (e.g., to track a target) based on an image (e.g., a doppler image) of a blood vessel.” [0452]).
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 Singanamalli in view of Puleo as outlined above with the alignment controller is further configured to perform acts comprising: tracking a motion of the portal vein in the image data over time as taught by Gertner, because continued advances in computing, miniaturization and economization of energy delivery technologies, and improved imaging will lead to still greater opportunities to apply energy from a distance into the patient and treat disease [0011].
Response to Arguments
Applicant's arguments filed 10/09/2025 have been fully considered but they are not persuasive.
Regarding the U.S.C. 103 rejection of Claims 1 and 14 the Applicant argues the following:
Accordingly, Applicant respectfully submits that Singanamalli and Puleo, taken alone or in a hypothetical combination, fail to teach or suggest "comparing the alignment score to one or more predetermined threshold ranges corresponding to delivery of a target therapy dosage to the subject" and "wherein the change comprises dynamically adjusting a therapy dosage delivery time based on a change in the alignment score over time relative to the predetermined threshold ranges," as generally recited by claims 1 and 14. Indeed, Applicant notes that neither reference discloses dynamically adjusting a therapy dosage delivery time based on a change in the alignment score relative to the predetermined threshold ranges. (Emphasis added.) For at least these reasons, Applicant respectfully requests withdrawal of the rejection of claims 1 and 14 under 35 U.S.C. §103 and allowance of the same.
However, further review of the references has resulted in the same references being interpreted as meeting the limitations.
It is also noted that under the broadest reasonable interpretation of Claim 1 the amended limitations require changing of therapy dosage delivery time depending on a change of the alignment (position & orientation).
Singanamalli discloses measuring the position and orientation of the probe in reference to the target region as well as defining an aligning period (no therapeutic energy delivery) and a delivering period (therapeutic energy delivery) (“the system waits for the target anatomy (in this case liver) to appear in the field of view before delivering the therapy. The identified probe placement is not suited for delivering the therapy and therefore the status indicates “aligning.” In FIG. 13, the therapy or neuromodulating energy dose is delivered upon determination that the anatomy of interest aligns with the anatomy in the field of view as identified by the neural network. The status indicates “delivering,” and the therapy beam is visualized in the ultrasound image. In FIG. 14, the system stops delivering the therapy even when focused on the target organ (i.e., the liver), and the total energy of the individual dose is complete as shown in this frame.” [0061]).
Singanamalli also teaches dynamically adjusting its time of dosage delivery depending on how long the probe remains aligned with the target region (“the system 10 may use the image data and the determined position of the region of interest 44 relative to the focal zone 48 to account for dosage delivery over time. For example, in an embodiment, the energy application device 12 may minimally adjust steering and/or focusing of energy delivery over the course of movement of the region of interest while adjusting other parameters. Based on identified movement of the region of interest 44 outside of the focal zone 48, the system 10 may calculate a total dose delivery. Accordingly, the movement may cause the system 10 to extend the period of dose delivery so that the total dose delivered directly to the region of interest 44 is within desired parameters and to account for periods when the region of interest 44 is outside of the focal zone 48 during delivery of energy. Further, the system 10 may also account for total delivery to areas outside of the region of interest 44 and adjust steering and/or focusing when energy applied outside of the region of interest 44 reaches a threshold.” [0054].
Taking the 2 citations from above it can be clearly seen that Singanamalli teaches tracking a target region through the use of neuromodulation device, determining whether the device is not aligned (no energy delivery) or is aligned (energy delivery), once the device is determined to be aligned the time of dosage delivery is dynamically adjusted to ensure maximum output to the target region and to stop once it is no longer aligned due to patient movement.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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
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/Steven Maldonado/
Patent Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797