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
The amendment filed on 5/18/2026 has been entered. Claims 1, 3-12, 14-18, and 20 remain pending the application.
Response to Arguments
Applicant's arguments filed on 5/18/2026 have been fully considered but they are moot.
Applicant argues on page 6 that the 112b issues have been addressed by amendment. While the Examiner generally agrees, the limitation “the support member” remains in claim 1. The Applicant appears to have corrected this issue in line 8 but it remains in lines 9-10. Accordingly, this claim is maintained.
Applicant argues on pages 6-9 that the previously cited art does not disclose the limitations to the claims related to rotating the sensing member relative to the support shaft. This grounds of rejection is moot in view of the new grounds of rejection necessitated by amendment which relies on Havel et al. (US20150094595, hereafter Havel) to disclose these limitations in the claims. Although previous claim 2 had similar limitations to the newly added limitations, new language related to rotating the sensing member “relative to the support shaft” has also been included. Accordingly, this argument is moot.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 3-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites the limitation “the support member” in lines 9-10. This limitation lacks antecedent basis, no support member has previously been set forth. Based on paragraphs 57-58 of the specification, the applicant appears to intend to have the sensing member move away from the support shaft ([0057-0058] “at least a portion of the sensing member may move radially away from the support shaft 12 (e.g., curving away from the support shaft 12) […] FIG. 4 further illustrates that the distal translation of the actuator 34 may result in the sensing member 16 bowing away from the support shaft 12”) so for examination purposes, this limitation will be interpreted as referring to the support shaft. The Applicant appears to have corrected this issue in line 8 but it remains in lines 9-10. Accordingly, this claim is rejected under 112b.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. (US20150366508, hereafter Chou), Nagale et al. (US20170035341, hereafter Nagale), and Havel et al. (US20150094595, hereafter Havel).
Regarding claim 1, Chou discloses in Figure 10 a method for imaging an organ (Chou, Para 151; “The flex-PCB catheter 100 can include one or more ultrasound transducers, such as ultrasound transducers 154, these transducers used to provide two or three dimensional distance information such as distance information used to create a two or three dimensional map of tissue, determine relative position of tissue such as tissue walls and/or determine device locations such as relative locations of one or more portions of a device of system 2 or another device.”), the method comprising:
positioning an ultrasound (Chou, Para 151; “The flex-PCB catheter 100 can include one or more ultrasound transducers, such as ultrasound transducers 154, these transducers used to provide two or three dimensional distance information such as distance information used to create a two or three dimensional map of tissue, determine relative position of tissue such as tissue walls and/or determine device locations such as relative locations of one or more portions of a device of system 2 or another device.”) (Chou, Para 46; “Each spline can comprise a plurality of pairs of electrodes and ultrasound transducers, with one electrode and one ultrasound transducer per pair.”) (Chou, Para 84; “As examples, types of electronic elements 150 can include, but are not limited to, electrodes, transducers, accelerometers, sensors, integrated circuits (e.g., semiconductors), and so on. As examples, such sensors can include, but are not limited to, temperature sensors, pressure sensors (e.g., strain gauges), voltage sensors, current sensors, acoustic sensors, and so on. As examples, such transducers can include, but are not limited to, ultrasound transducers, sound transducers, heating elements, cooling elements, and so on.”) catheter assembly into the organ (Chou, Para 52; “introducing the expandable assembly into a region of the body and expanding the expandable assembly; and supplying at least one electrical signal to the plurality of electronic elements via at least some of the plurality of communication paths. The region of the body can comprise a cardiac chamber.”) (Chou, Para 10; “The expandable assembly can be further configured for insertion into a heart chamber”), the ultrasound catheter assembly including:
a support shaft (support shaft 1010) (Chou, Para 148; “catheter 1000 includes a shaft 1010. Shaft 920 includes an inner lumen 912 configured to slidingly receive shaft 1010”);
a sensing member (splines 120) coupled to the support shaft; and
one or more ultrasound sensors (ultrasound transducers 154) (Chou, Para 149; “Expandable assembly 110 includes a plurality of electrodes 152 and a plurality of ultrasound transducers 154 on splines 120 forming a basket array or basket catheter, in this embodiment.”) disposed along the sensing member;
shifting the sensing member relative to the support shaft within the organ such that at least a portion of the sensing member moves away from the support shaft (Chou, Para 149; “Attached to the distal end of shaft 920 is expandable assembly 110, which can be of similar construction to expandable assembly 110 of FIG. 1. As shown in FIG. 10, expandable assembly 110 has been advanced from the distal end of shaft 14 of introducer 10 such that expandable assembly 110 is radially expanded. Expandable assembly 110 includes a plurality of electrodes 152 and a plurality of ultrasound transducers 154 on splines 120 forming a basket array or basket catheter, in this embodiment.”) (Chou, Para 74; “handle 112 includes a knob, lever, switch or other control, control 113. Control 113 can be configured to perform a function such as, for example, steering the distal end of shaft 114; controlling the expansion and/or contraction of expandable assembly 110 such as via retraction or advancement, respectively, of one or more control rods not shown, making an electrical connection such as to provide power to a component of expandable assembly 110 or electrically connecting to a sensor of expandable assembly 110, and combinations of these.”) (Chou, Para 50; “where the lumen can be constructed and arranged to slidingly receive the elongate shaft and the expandable assembly. The expandable assembly can be configured to radially expand as it exits the sheath lumen.”).
Chou does not clearly and explicitly disclose positioning the ultrasound catheter assembly into a bladder and rotating the sensing member relative to the support shaft around a longitudinal axis of the support shaft, such that the sensing member sweeps around an inner surface of the bladder.
In an analogous inserted imaging catheter field of endeavor Nagale discloses positioning a ultrasound catheter assembly into a bladder (Nagale, Para 9; “The present disclosure, in its various aspects, provides systems, devices and methods for spatially locating abnormalities within the bladder and/or generating virtual maps of the inner surface of the bladder and particularly of the interface between the device and the bladder wall. These aspects may facilitate targeted interventions for conditions such as OAB. In contrast to the systemic interventions currently used to treat OAB, the aspects of the present disclosure are minimally invasive and offer a reduced risk of side effects”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chou to include positioning the ultrasound catheter assembly into a bladder in order to identify abnormalities in the bladder for treatment in a minimally invasive manner which reduces side effects as needed as taught by Nagale (Nagale, Para 3-9).
In an analogous inserted imaging catheter field of endeavor Havel discloses rotating a sensor relative to a support shaft around a longitudinal axis of the support shaft (Havel, Figure 1) (Havel, Para 44; " As will be discussed further below, pivot mechanism 30 allows transducer 28 to be turned around a rotation axis (axis A) of device 20 as well as pivoted around a pivot axis substantially perpendicular to the rotation axis. This allows the direction of ultrasound emission and reception to extend forward (axially relative to the rotation axis) and laterally (radially relative to the rotation axis). In the illustrated embodiments, the rotation axis is the longitudinal axis (i.e. extending axially through catheter 22) of device 20, and the pivot axis is a lateral axis (e.g. perpendicular to the longitudinal axis).”) (Havel, Para 49; "Cannula 52 as shown extends generally along the rotation axis. In some embodiments, cannula 52 has an axial center which is aligned with the rotation axis.") (Havel, Para 53; "Pivot member 57 is therefore rotatable through a path (or rotation path) over cannula 52 (and its wire guide path) about both the pivot axis and the rotation axis. In other words, the wire guide channel is positioned substantially parallel to the rotation axis and radially inward of the most radially outer extent of the path. Similarly, in some embodiments the wire guide channel is positioned substantially parallel to the rotation axis and radially inward of the most radially inward extent of the path. [...] In other words, the wire guide channel is positioned substantially parallel to the rotation axis and radially inward of the most radially outer extent of the path. Similarly, in some embodiments the wire guide channel is positioned substantially parallel to the rotation axis and radially inward of the most radially inward extent of the path.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chou to include rotating the sensing member relative to the support shaft around a longitudinal axis of the support shaft, such that the sensing member sweeps around an inner surface of the bladder in order to more accurately and efficiently allow for ultrasound imaging in three dimensions in a more reliable manner as taught by Havel (Havel, Para 13).
Regarding claim 4, Chou as modified by Nagale and Havel above discloses all of the limitations of claim 1 as discussed above.
Chou further discloses wherein the sensing member is coupled to a distal end of the support shaft (Chou, Figure 10 showing splines 120 connected to the distal end of support shaft 1010).
Regarding claim 7, Chou as modified by Nagale and Havel above discloses all of the limitations of claim 1 as discussed above.
Chou further discloses in Figure 1 wherein the ultrasound catheter assembly is coupled to a hub (handle 112) and the hub is operably coupled to an actuator (Chou, Para 74; “handle 112 includes a knob, lever, switch or other control, control 113. Control 113 can be configured to perform a function such as, for example, steering the distal end of shaft 114; controlling the expansion and/or contraction of expandable assembly 110 such as via retraction or advancement, respectively, of one or more control rods not shown, making an electrical connection such as to provide power to a component of expandable assembly 110 or electrically connecting to a sensor of expandable assembly 110, and combinations of these.”).
Regarding claim 8, Chou as modified by Nagale and Havel above discloses all of the limitations of claim 7 as discussed above.
Chou further discloses wherein a proximal end region of the sensing member is coupled to the actuator and wherein the actuator is in translational engagement within the hub (Chou, Para 74; “handle 112 includes a knob, lever, switch or other control, control 113. Control 113 can be configured to perform a function such as, for example, steering the distal end of shaft 114; controlling the expansion and/or contraction of expandable assembly 110 such as via retraction or advancement, respectively, of one or more control rods not shown, making an electrical connection such as to provide power to a component of expandable assembly 110 or electrically connecting to a sensor of expandable assembly 110, and combinations of these.”).
Regarding claim 9, Chou as modified by Nagale and Havel above discloses all of the limitations of claim 1 as discussed above.
Chou further discloses wherein shifting the sensing member relative to the support member within the bladder includes bowing a middle region of the sensing member away from the support shaft (Chou, Para 74; “handle 112 includes a knob, lever, switch or other control, control 113. Control 113 can be configured to perform a function such as, for example, steering the distal end of shaft 114; controlling the expansion and/or contraction of expandable assembly 110 such as via retraction or advancement, respectively, of one or more control rods not shown, making an electrical connection such as to provide power to a component of expandable assembly 110 or electrically connecting to a sensor of expandable assembly 110, and combinations of these.”) (Chou, Para 50; “where the lumen can be constructed and arranged to slidingly receive the elongate shaft and the expandable assembly. The expandable assembly can be configured to radially expand as it exits the sheath lumen”).
Regarding claim 10, Chou as modified by Nagale and Havel above discloses all of the limitations of claim 1 as discussed above.
Chou further discloses translating the sensing member in a proximal-to-distal direction relative to the support shaft such that the one or more ultrasound sensors shift to a position closer to the inner surface of the bladder (Chou, Para 74; “handle 112 includes a knob, lever, switch or other control, control 113. Control 113 can be configured to perform a function such as, for example, steering the distal end of shaft 114; controlling the expansion and/or contraction of expandable assembly 110 such as via retraction or advancement, respectively, of one or more control rods not shown, making an electrical connection such as to provide power to a component of expandable assembly 110 or electrically connecting to a sensor of expandable assembly 110, and combinations of these.”) (Chou, Para 50; “where the lumen can be constructed and arranged to slidingly receive the elongate shaft and the expandable assembly. The expandable assembly can be configured to radially expand as it exits the sheath lumen”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Chou, Nagale, and Havel as applied to claim 1 above, and further in view of Hirooka et al. (US20030045768, hereafter Hirooka).
Regarding claim 3, Chou as modified by Nagale and Havel above discloses all of the limitations of claim 1 as discussed above.
Chou does not clearly and explicitly disclose measuring and/or marking boundaries of one or more of a tumor, a cyst, a lesion, and a tissue anomaly via the one or more ultrasound sensors.
In an analogous ultrasound catheter device field of endeavor Hirooka discloses measuring and/or marking boundaries of one or more of a tumor, a cyst, a lesion, and a tissue anomaly via the one or more ultrasound sensors (Hirooka, Para 200; “When the rotating ultrasonic transducer 29 radiates ultrasonic waves in all directions within 360° as shown in FIG. 17, part of the radiated ultrasonic waves is reflected from the reflecting mirror surface 9 b and propagated forwards.”) (Hirooka, Para 207; “Otherwise, a radial image representing areas in a region located in all directions within 360° can be produced in order to selectively observe and treat a lesion.”) (Hirooka, Para 267-268; “This causes the cutter 155 to rotate to achieve treatment. Assume that the ultrasonic transducer 29 is rotated in order to perform ultrasonic examination and a tumor or the like is identified on the wall of a lumen […]the intended tumor or the like can be scraped”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chou to measuring and/or marking boundaries of one or more of a tumor, a cyst, a lesion, and a tissue anomaly via the one or more ultrasound sensors in order to observe and treat lesions as needed as taught by Nagale (Nagale, Para 207 and 268) which improves patient health.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Chou, Nagale, and Havel as applied to claim 4 above, and further in view of Harlev et al. (US20090171274, hereafter Harlev).
Regarding claim 5, Chou as modified by Nagale and Havel above discloses all of the limitations of claim 4 as discussed above.
Chou does not clearly and explicitly disclose a support member extending between the sensing member and the support shaft.
In an analogous expandable and collapsable catheter device field of endeavor Harlev discloses in Figure 14 a support member (tether 300) extending between a sensing member and a support shaft (Harlev, Para 99; “FIG. 14 shows a strategy for constraining the deployment providing tight control over the final shape of the deployed array. For example tether 300 may emerge from the central shaft in FIG. 14 to restrain the motion of the splines or limbs.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chou to include a support member extending between the sensing member and the support shaft in order to control the positioning or motion of the spline as needed as taught by Harlev (Harlev, Para 99) which increases the amount of control the user has over the device.
Regarding claim 6, Chou as modified by Nagale and Harlev above discloses all of the limitations of claim 5 as discussed above.
Chou does not clearly and explicitly disclose wherein the support member is coupled to the support shaft proximal of the distal end of the support shaft.
In an analogous expandable and collapsable catheter device field of endeavor Harlev discloses in Figure 14 a support member (tether 300) extending between a sensing member and a support shaft, wherein the support member is coupled to the support shaft proximal of the distal end of the support shaft (Harlev, Figure 14 showing this) (Harlev, Para 99; “FIG. 14 shows a strategy for constraining the deployment providing tight control over the final shape of the deployed array. For example tether 300 may emerge from the central shaft in FIG. 14 to restrain the motion of the splines or limbs.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chou wherein the support member is coupled to the support shaft proximal of the distal end of the support shaft in order to control the positioning or motion of the spline as needed as taught by Harlev (Harlev, Para 99) which increases the amount of control the user has over the device.
Claims 11-12, 14-15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. (US20150366508, hereafter Chou), Nagale et al. (US20170035341, hereafter Nagale), Havel et al. (US20150094595, hereafter Havel), and Harlev et al. (US20090171274, hereafter Harlev).
Regarding claim 11, Chou discloses in Figure 10 a method for imaging an organ (Chou, Para 151; “The flex-PCB catheter 100 can include one or more ultrasound transducers, such as ultrasound transducers 154, these transducers used to provide two or three dimensional distance information such as distance information used to create a two or three dimensional map of tissue, determine relative position of tissue such as tissue walls and/or determine device locations such as relative locations of one or more portions of a device of system 2 or another device.”), the method comprising:
positioning an ultrasound (Chou, Para 151; “The flex-PCB catheter 100 can include one or more ultrasound transducers, such as ultrasound transducers 154, these transducers used to provide two or three dimensional distance information such as distance information used to create a two or three dimensional map of tissue, determine relative position of tissue such as tissue walls and/or determine device locations such as relative locations of one or more portions of a device of system 2 or another device.”) (Chou, Para 46; “Each spline can comprise a plurality of pairs of electrodes and ultrasound transducers, with one electrode and one ultrasound transducer per pair.”) (Chou, Para 84; “As examples, types of electronic elements 150 can include, but are not limited to, electrodes, transducers, accelerometers, sensors, integrated circuits (e.g., semiconductors), and so on. As examples, such sensors can include, but are not limited to, temperature sensors, pressure sensors (e.g., strain gauges), voltage sensors, current sensors, acoustic sensors, and so on. As examples, such transducers can include, but are not limited to, ultrasound transducers, sound transducers, heating elements, cooling elements, and so on.”) catheter assembly into the organ (Chou, Para 52; “introducing the expandable assembly into a region of the body and expanding the expandable assembly; and supplying at least one electrical signal to the plurality of electronic elements via at least some of the plurality of communication paths. The region of the body can comprise a cardiac chamber.”) (Chou, Para 10; “The expandable assembly can be further configured for insertion into a heart chamber”), the ultrasound catheter assembly including:
a support shaft having a proximal end region and a distal end region (support shaft 1010) (Chou, Para 148; “catheter 1000 includes a shaft 1010. Shaft 920 includes an inner lumen 912 configured to slidingly receive shaft 1010”);
a sensing member having a proximal end region and a distal end region (splines 120), the distal end region of the sensing member coupled to the distal end region of the support shaft (Chou, Figure 10 showing this); and
one or more ultrasound sensors (ultrasound transducers 154) (Chou, Para 149; “Expandable assembly 110 includes a plurality of electrodes 152 and a plurality of ultrasound transducers 154 on splines 120 forming a basket array or basket catheter, in this embodiment.”) disposed along the sensing member;
shifting the sensing member relative to the support shaft within the organ such that at least a portion of the sensing member moves away from the support shaft (Chou, Para 149; “Attached to the distal end of shaft 920 is expandable assembly 110, which can be of similar construction to expandable assembly 110 of FIG. 1. As shown in FIG. 10, expandable assembly 110 has been advanced from the distal end of shaft 14 of introducer 10 such that expandable assembly 110 is radially expanded. Expandable assembly 110 includes a plurality of electrodes 152 and a plurality of ultrasound transducers 154 on splines 120 forming a basket array or basket catheter, in this embodiment.”) (Chou, Para 74; “handle 112 includes a knob, lever, switch or other control, control 113. Control 113 can be configured to perform a function such as, for example, steering the distal end of shaft 114; controlling the expansion and/or contraction of expandable assembly 110 such as via retraction or advancement, respectively, of one or more control rods not shown, making an electrical connection such as to provide power to a component of expandable assembly 110 or electrically connecting to a sensor of expandable assembly 110, and combinations of these.”) (Chou, Para 50; “where the lumen can be constructed and arranged to slidingly receive the elongate shaft and the expandable assembly. The expandable assembly can be configured to radially expand as it exits the sheath lumen.”).
Chou does not clearly and explicitly disclose positioning the ultrasound catheter assembly into a bladder, rotating the sensing member relative to the support shaft around a longitudinal axis of the support shaft, such that the sensing member sweeps around an inner surface of the bladder, and a support member having a first end coupled to the sensing member and a second end coupled to the support shaft.
In an analogous inserted imaging catheter field of endeavor Nagale discloses positioning a ultrasound catheter assembly into a bladder (Nagale, Para 9; “The present disclosure, in its various aspects, provides systems, devices and methods for spatially locating abnormalities within the bladder and/or generating virtual maps of the inner surface of the bladder and particularly of the interface between the device and the bladder wall. These aspects may facilitate targeted interventions for conditions such as OAB. In contrast to the systemic interventions currently used to treat OAB, the aspects of the present disclosure are minimally invasive and offer a reduced risk of side effects”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chou to include positioning the ultrasound catheter assembly into a bladder in order to identify abnormalities in the bladder for treatment in a minimally invasive manner which reduces side effects as needed as taught by Nagale (Nagale, Para 3-9).
In an analogous inserted imaging catheter field of endeavor Havel discloses rotating a sensor relative to a support shaft around a longitudinal axis of the support shaft (Havel, Figure 1) (Havel, Para 44; " As will be discussed further below, pivot mechanism 30 allows transducer 28 to be turned around a rotation axis (axis A) of device 20 as well as pivoted around a pivot axis substantially perpendicular to the rotation axis. This allows the direction of ultrasound emission and reception to extend forward (axially relative to the rotation axis) and laterally (radially relative to the rotation axis). In the illustrated embodiments, the rotation axis is the longitudinal axis (i.e. extending axially through catheter 22) of device 20, and the pivot axis is a lateral axis (e.g. perpendicular to the longitudinal axis).”) (Havel, Para 49; "Cannula 52 as shown extends generally along the rotation axis. In some embodiments, cannula 52 has an axial center which is aligned with the rotation axis.") (Havel, Para 53; "Pivot member 57 is therefore rotatable through a path (or rotation path) over cannula 52 (and its wire guide path) about both the pivot axis and the rotation axis. In other words, the wire guide channel is positioned substantially parallel to the rotation axis and radially inward of the most radially outer extent of the path. Similarly, in some embodiments the wire guide channel is positioned substantially parallel to the rotation axis and radially inward of the most radially inward extent of the path. [...] In other words, the wire guide channel is positioned substantially parallel to the rotation axis and radially inward of the most radially outer extent of the path. Similarly, in some embodiments the wire guide channel is positioned substantially parallel to the rotation axis and radially inward of the most radially inward extent of the path.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chou to include rotating the sensing member relative to the support shaft around a longitudinal axis of the support shaft, such that the sensing member sweeps around an inner surface of the bladder in order to more accurately and efficiently allow for ultrasound imaging in three dimensions in a more reliable manner as taught by Havel (Havel, Para 13).
In an analogous expandable and collapsable catheter device field of endeavor Harlev discloses in Figure 14 a support member (tether 300) having a first end coupled to a sensing member and a second end coupled to a support shaft (Harlev, Para 99; “FIG. 14 shows a strategy for constraining the deployment providing tight control over the final shape of the deployed array. For example tether 300 may emerge from the central shaft in FIG. 14 to restrain the motion of the splines or limbs.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chou to include a support member having a first end coupled to the sensing member and a second end coupled to the support shaft in order to control the positioning or motion of the spline as needed as taught by Harlev (Harlev, Para 99) which increases the amount of control the user has over the device.
Regarding claim 12, Chou as modified by Nagale, Havel, and Harlev above discloses all of the limitations of claim 11 as discussed above.
Chou further discloses shifting the sensing member relative to the support shaft within the bladder such that at least a portion of the sensing member moves away from the support shaft (Chou, Para 149; “Attached to the distal end of shaft 920 is expandable assembly 110, which can be of similar construction to expandable assembly 110 of FIG. 1. As shown in FIG. 10, expandable assembly 110 has been advanced from the distal end of shaft 14 of introducer 10 such that expandable assembly 110 is radially expanded. Expandable assembly 110 includes a plurality of electrodes 152 and a plurality of ultrasound transducers 154 on splines 120 forming a basket array or basket catheter, in this embodiment.”) (Chou, Para 74; “handle 112 includes a knob, lever, switch or other control, control 113. Control 113 can be configured to perform a function such as, for example, steering the distal end of shaft 114; controlling the expansion and/or contraction of expandable assembly 110 such as via retraction or advancement, respectively, of one or more control rods not shown, making an electrical connection such as to provide power to a component of expandable assembly 110 or electrically connecting to a sensor of expandable assembly 110, and combinations of these.”) (Chou, Para 50; “where the lumen can be constructed and arranged to slidingly receive the elongate shaft and the expandable assembly. The expandable assembly can be configured to radially expand as it exits the sheath lumen.”).
Regarding claim 14, Chou as modified by Nagale, Havel, and Harlev above discloses all of the limitations of claim 11 as discussed above.
Chou further discloses in Figure 1 wherein the ultrasound catheter assembly includes a hub (handle 112) operatively coupled to an actuator (Chou, Para 74; “handle 112 includes a knob, lever, switch or other control, control 113. Control 113 can be configured to perform a function such as, for example, steering the distal end of shaft 114; controlling the expansion and/or contraction of expandable assembly 110 such as via retraction or advancement, respectively, of one or more control rods not shown, making an electrical connection such as to provide power to a component of expandable assembly 110 or electrically connecting to a sensor of expandable assembly 110, and combinations of these.”).
Regarding claim 15, Chou as modified by Nagale, Havel, and Harlev above discloses all of the limitations of claim 14 as discussed above.
Chou further discloses moving the actuator such that the sensing member bows and/or bends in one or more directions away from the support shaft (Chou, Para 74; “handle 112 includes a knob, lever, switch or other control, control 113. Control 113 can be configured to perform a function such as, for example, steering the distal end of shaft 114; controlling the expansion and/or contraction of expandable assembly 110 such as via retraction or advancement, respectively, of one or more control rods not shown, making an electrical connection such as to provide power to a component of expandable assembly 110 or electrically connecting to a sensor of expandable assembly 110, and combinations of these.”).
Regarding claim 17, Chou as modified by Nagale, Havel, and Harlev above discloses all of the limitations of claim 11 as discussed above.
Chou does not clearly and explicitly disclose wherein the first end of the support member is pivotably coupled to the sensing member.
However, Nagale further discloses wherein a first end of the support member is pivotably coupled to a sensing member (Nagale, Figure 14 showing this) (Nagale, Para 99; “FIG. 14 shows a strategy for constraining the deployment providing tight control over the final shape of the deployed array. For example tether 300 may emerge from the central shaft in FIG. 14 to restrain the motion of the splines or limbs.”) (Nagale, Figures 10A and 10B showing the expanding splines which; a person having ordinary skill in the art would understand that the support member must be pivotably coupled to allow for the collapse and expansion of the splines).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Chou, Nagale, Havel, and Harlev as applied to claim 11 above, and further in view of Lee et al. (US20060241748, hereafter Lee).
.Regarding claim 16, Chou as modified by Nagale, Havel, and Harlev above discloses all of the limitations of claim 11 as discussed above.
Chou does not clearly and explicitly disclose wherein the second end of the support member includes a collar slidably coupled to the support shaft.
In an analogous inserted expandable device field of endeavor Lee discloses wherein a second end of the support member includes a collar slidably coupled to a support shaft (core catheter 615) (Lee, Para 127; “As the actuating catheter 610 is advanced with respect to the core catheter 615, the radial support struts 636 force the radial implant support arms 630 upward and outward in the fashion of an umbrella frame. Thus the actuating catheter 610, core catheter 615, radial support struts 636, and radial support arms 630 in combination form a deployment umbrella 642.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chou wherein the second end of the support member includes a collar slidably coupled to the support shaft in order to allow for smoother expansion and collapse of the device as needed as taught by Lee (Lee, Para 137) which improves precision and ease of use.
Claims 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. (US20150366508, hereafter Chou), Havel et al. (US20150094595, hereafter Havel), and Harlev et al. (US20090171274, hereafter Harlev).
Regarding claim 18, Chou discloses in Figure 10 a method for imaging a body cavity of a patient or subject (Chou, Para 151; “The flex-PCB catheter 100 can include one or more ultrasound transducers, such as ultrasound transducers 154, these transducers used to provide two or three dimensional distance information such as distance information used to create a two or three dimensional map of tissue, determine relative position of tissue such as tissue walls and/or determine device locations such as relative locations of one or more portions of a device of system 2 or another device.”), the method comprising:
positioning an ultrasound (Chou, Para 151; “The flex-PCB catheter 100 can include one or more ultrasound transducers, such as ultrasound transducers 154, these transducers used to provide two or three dimensional distance information such as distance information used to create a two or three dimensional map of tissue, determine relative position of tissue such as tissue walls and/or determine device locations such as relative locations of one or more portions of a device of system 2 or another device.”) (Chou, Para 46; “Each spline can comprise a plurality of pairs of electrodes and ultrasound transducers, with one electrode and one ultrasound transducer per pair.”) (Chou, Para 84; “As examples, types of electronic elements 150 can include, but are not limited to, electrodes, transducers, accelerometers, sensors, integrated circuits (e.g., semiconductors), and so on. As examples, such sensors can include, but are not limited to, temperature sensors, pressure sensors (e.g., strain gauges), voltage sensors, current sensors, acoustic sensors, and so on. As examples, such transducers can include, but are not limited to, ultrasound transducers, sound transducers, heating elements, cooling elements, and so on.”) catheter assembly into the body cavity (Chou, Para 52; “introducing the expandable assembly into a region of the body and expanding the expandable assembly; and supplying at least one electrical signal to the plurality of electronic elements via at least some of the plurality of communication paths. The region of the body can comprise a cardiac chamber.”) (Chou, Para 10; “The expandable assembly can be further configured for insertion into a heart chamber”), the ultrasound catheter assembly including:
a support shaft having a proximal end region, a distal end region, and a longitudinal axis (support shaft 1010) (Chou, Para 148; “catheter 1000 includes a shaft 1010. Shaft 920 includes an inner lumen 912 configured to slidingly receive shaft 1010”);
a sensing member having a proximal end region and a distal end region (splines 120), the distal end region of the sensing member coupled to the distal end region of the support shaft (Chou, Figure 10 showing this); and
one or more ultrasound sensors (ultrasound transducers 154) (Chou, Para 149; “Expandable assembly 110 includes a plurality of electrodes 152 and a plurality of ultrasound transducers 154 on splines 120 forming a basket array or basket catheter, in this embodiment.”) disposed along the sensing member;
bowing a medial region of the sensing member away from the longitudinal axis such that the medial region of the sensing member moves radially away from the longitudinal axis of the support shaft (Chou, Para 149; “Attached to the distal end of shaft 920 is expandable assembly 110, which can be of similar construction to expandable assembly 110 of FIG. 1. As shown in FIG. 10, expandable assembly 110 has been advanced from the distal end of shaft 14 of introducer 10 such that expandable assembly 110 is radially expanded. Expandable assembly 110 includes a plurality of electrodes 152 and a plurality of ultrasound transducers 154 on splines 120 forming a basket array or basket catheter, in this embodiment.”) (Chou, Para 74; “handle 112 includes a knob, lever, switch or other control, control 113. Control 113 can be configured to perform a function such as, for example, steering the distal end of shaft 114; controlling the expansion and/or contraction of expandable assembly 110 such as via retraction or advancement, respectively, of one or more control rods not shown, making an electrical connection such as to provide power to a component of expandable assembly 110 or electrically connecting to a sensor of expandable assembly 110, and combinations of these.”) (Chou, Para 50; “where the lumen can be constructed and arranged to slidingly receive the elongate shaft and the expandable assembly. The expandable assembly can be configured to radially expand as it exits the sheath lumen.”).
Chou does not clearly and explicitly disclose rotating the sensing member relative to the support shaft around a longitudinal axis of the support shaft, such that the sensing member sweeps around an inner surface of the bladder and a support member having a first end coupled to the sensing member and a second end coupled to the support shaft.
In an analogous inserted imaging catheter field of endeavor Nagale discloses positioning a ultrasound catheter assembly into a bladder (Nagale, Para 9; “The present disclosure, in its various aspects, provides systems, devices and methods for spatially locating abnormalities within the bladder and/or generating virtual maps of the inner surface of the bladder and particularly of the interface between the device and the bladder wall. These aspects may facilitate targeted interventions for conditions such as OAB. In contrast to the systemic interventions currently used to treat OAB, the aspects of the present disclosure are minimally invasive and offer a reduced risk of side effects”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chou to include positioning the ultrasound catheter assembly into a bladder in order to identify abnormalities in the bladder for treatment in a minimally invasive manner which reduces side effects as needed as taught by Nagale (Nagale, Para 3-9).
In an analogous inserted imaging catheter field of endeavor Havel discloses rotating a sensor relative to a support shaft around a longitudinal axis of the support shaft (Havel, Figure 1) (Havel, Para 44; " As will be discussed further below, pivot mechanism 30 allows transducer 28 to be turned around a rotation axis (axis A) of device 20 as well as pivoted around a pivot axis substantially perpendicular to the rotation axis. This allows the direction of ultrasound emission and reception to extend forward (axially relative to the rotation axis) and laterally (radially relative to the rotation axis). In the illustrated embodiments, the rotation axis is the longitudinal axis (i.e. extending axially through catheter 22) of device 20, and the pivot axis is a lateral axis (e.g. perpendicular to the longitudinal axis).”) (Havel, Para 49; "Cannula 52 as shown extends generally along the rotation axis. In some embodiments, cannula 52 has an axial center which is aligned with the rotation axis.") (Havel, Para 53; "Pivot member 57 is therefore rotatable through a path (or rotation path) over cannula 52 (and its wire guide path) about both the pivot axis and the rotation axis. In other words, the wire guide channel is positioned substantially parallel to the rotation axis and radially inward of the most radially outer extent of the path. Similarly, in some embodiments the wire guide channel is positioned substantially parallel to the rotation axis and radially inward of the most radially inward extent of the path. [...] In other words, the wire guide channel is positioned substantially parallel to the rotation axis and radially inward of the most radially outer extent of the path. Similarly, in some
In an analogous expandable and collapsable catheter device field of endeavor Harlev discloses in Figure 14 a support member (tether 300) having a first end coupled to a sensing member and a second end coupled to a support shaft (Harlev, Para 99; “FIG. 14 shows a strategy for constraining the deployment providing tight control over the final shape of the deployed array. For example tether 300 may emerge from the central shaft in FIG. 14 to restrain the motion of the splines or limbs.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chou to include a support member having a first end coupled to the sensing member and a second end coupled to the support shaft in order to control the positioning or motion of the spline as needed as taught by Harlev (Harlev, Para 99) which increases the amount of control the user has over the device.
Regarding claim 20, Chou as modified by Havel and Harlev above discloses all of the limitations of claim 18 as discussed above.
Chou further discloses translating the sensing member in a proximal-to-distal direction relative to the support shaft such that the one or more ultrasound sensors shift to a position closer to the inner surface of the bladder (Chou, Para 74; “handle 112 includes a knob, lever, switch or other control, control 113. Control 113 can be configured to perform a function such as, for example, steering the distal end of shaft 114; controlling the expansion and/or contraction of expandable assembly 110 such as via retraction or advancement, respectively, of one or more control rods not shown, making an electrical connection such as to provide power to a component of expandable assembly 110 or electrically connecting to a sensor of expandable assembly 110, and combinations of these.”) (Chou, Para 50; “where the lumen can be constructed and arranged to slidingly receive the elongate shaft and the expandable assembly. The expandable assembly can be configured to radially expand as it exits the sheath lumen”).
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.
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/JOHN D LI/Primary Examiner, Art Unit 3798
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