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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted was filed on 12/10/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed 12/18/2025 has been entered. Claim 18 has been canceled. Accordingly, claims 1-17 and 19-20 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 09/18/2025.
Response to Arguments
Applicant’s arguments with respect to claims 1, 12, 17, and claims depending therefrom have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues Govari fails to disclose or teach board edge connectors. Reddersen (US5330370) is now relied upon for teaching a plurality of inline connection pads and a board edge connector that is configured to receive an edge of the printed circuit board, wherein the plurality of inline connection pads slide into and mate with the board edge connector.
Reddersen teaches an electronic device (10) comprising a handle assembly including a printed circuit board (20) (Figs. 1-2, Column 2 lines 32-56). Reddersen teaches wherein the printed circuit board (20) has an edge connector (21) comprising a plurality of inline connection pads (edge contacts 22) disposed on its edge (Figs. 1-3, Column 3 lines 17-44). Reddersen further teaches a dongle (38) comprising a board edge connector (30) configured to receive the edge of the printed circuit board (20) and wherein the plurality of inline connection pads (22) of the edge connector (21) slide into and mate with the board edge connector (30) (Figs 1-2, Column 2 lines 32-56, “The first end connector 30 includes tabs 34, 36 which slide into and mate with corresponding slots 24, 26 in the body of the handle of the scanner 10”). As shown in figure 2 reproduced below, the edge connector (21) comprising the plurality of inline connection pads (22) and the dongle (38) comprising the board edge connector (30) are configured to slide into one another and mate (Fig. 2).
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It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall in view of Govari to have the printed circuit board (PCB) include a plurality of inline connection pads configured to slide in and mate with a board edge connector of the dongle as taught by Reddersen (Figs. 1-3, Column 2 lines 32-56, Column 3 lines 17-44). The direct mating of the inline connection pads and board edge connector may improve reliability and robustness of the electrical connection. Moreover the inline pads allowing the dongle to mate directly with the PCB edge may result in a slimmer design shown by Reddersen (Fig. 2) which may save vertical space. In addition, this type of electrical interfacing between edge connectors of a PCB and a corresponding socket or board edge connector is well-known and conventional.
Claim Objections
Claim 1 is objected to because of the following informalities:
“wherein the inline connection pads slide” should be corrected to:
“wherein the plurality of inline connection pads slide”
Claim 12 is objected to because of the following informalities:
“an imaging device that isconfigured to” should be corrected to:
“an imaging device that is configured to”
Claim 16 is objected to because of the following informalities:
“wherein the plurality of steering cables that is connected to the printed circuit board” should be corrected to:
“wherein the plurality of steering cables are connected to the printed circuit board”
Claim 17 is objected to because of the following informalities:
“and wherein the dongle is coupled” should be corrected to:
“wherein the dongle is coupled”
“first printed circuit board wherein the interposer…” should be corrected to:
“first printed circuit board; wherein the interposer…”
Appropriate correction is required.
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 8-9 and 19 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.
Claim 8 recites the limitation "the plurality of transducer array elements". There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites “…connected to the printed circuit board”. It is unclear which printed circuit board claim 19 are referring to, because claim 17 upon which claims 19 depends on recites “a first printed circuit board” and “a second printed circuit board”. For purposes of examination, it will be interpreted for the printed circuit board recited in claim 19 to refer to the “first printed circuit board”.
Claim 9 is rejected by virtue of dependency on rejected claim 8.
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, 7, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Stigall (US20190053783; cited in the IDS filed 01/14/2025) in view of Govari (US20070185397) and Reddersen (US5330370).
Regarding claim 1, Stigall teaches an ultrasonic catheter (210) configured for use with an ultrasonic imaging system (160, 200), the ultrasonic catheter (210) having a longitudinal axis, a proximal end (206), and a distal end (204), the ultrasonic catheter (210) comprising (see re-produced Fig. 2 below and the associated pars., [0025], “the ultrasound device 110 is a catheter”, [0043-0045], “In particular, the ultrasound system 200 may have the same functionality as the ultrasound system 100”, [0048]):
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a handle assembly (220) (Fig. 2, [0043-0044]);
a catheter shaft (208) connected to the handle assembly (220) at the proximal end (206) (Fig. 2, [0043]);
an ultrasonic transducer array (261) connected to the catheter shaft (208) at the distal end (204) of (Figs. 2-3, [0043], [0049], [0051]); and
a dongle (222, 224) communicatively connected to the ultrasonic transducer array (261) (Fig. 2, [0043-0045]),
the dongle (222, 224) being configured to be communicatively connected to an imaging device (160, 200) to communicate the ultrasound signals (Fig. 2, [0045], “These ultrasound echoes may be received by the ultrasound transducer elements, as shown in more detail with reference to FIG. 4. The connector 224 may transfer the received echo signals to the PIM 150 and/or ultrasound processing system 160 where an ultrasound image based on the received echo signals is reconstructed and displayed on the monitor 170”).
However, Stigall fails to explicitly teach wherein the handle assembly includes a printed circuit board and wherein the dongle comprises a connector that is configured to receive the edge of the printed circuit board.
In an analogous ultrasonic catheter field of endeavor, Govari teaches such a feature. Govari teaches ultrasonic catheters (22, 50) (Figs. 1 & 2A-2B, [0028-0029], [0034], [0040]). Govari teaches wherein these ultrasonic catheters (22, 50) include a handle (38, 52, 54) (Fig. 1, [0030-0031], “connectors 52 and 54 are mechanically configured to form a sort of ‘split handle’”). Moreover, Govari teaches wherein the handles (38, 52, 54) include a circuit (48, 56) (Figs. 1 & 2A-2B, [0030-0031]). Govari therefore teaches an ultrasonic catheter comprising a handle assembly including a circuit board. Govari further teaches a dongle comprising an adapter (51) configured to connect the catheter (50) to a console (24) (Figs. 1 & 2B, [0006], [0031]). See figure 1 below for the dongle (51).
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Govari teaches wherein the adapter (51) [i.e. dongle] includes mating receptacles (84) which mate with connector pins (82) of the circuit board (56) of the handle (52) (Fig. 2B, [0034]). As shown in figure 2B, the receptacles (84) comprises a connector for connecting the edges of the two circuit boards 56 and 58.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall to include a circuit board in the handle and a corresponding adapter for connecting to the circuit board as taught by Govari (Figs. 1 & 2A-2B, [0030-0031], [0034]). It is typical for a circuit to be located in the handle for convenience and the circuit may include controls for steering the catheter as recognized by Govari ([0030]). Moreover, Govari teaches wherein the use of the adapter configured to connect to the catheter may result in reduced cost of the disposable part of a system by allowing for reuse of certain components (i.e. cables and connectors) without sterilization as recognized by Govari ([0031]); the board edge connector of the adapter predictably allows for electrical connection of a circuit board of the handle to transmit signals to a console (24) (Figs. 1 & 2B).
However, the modified combination noted above fails to teach wherein the printed circuit board has a plurality of inline connection pads disposed on an edge of the printed circuit board; and wherein the dongle comprises a board edge connector that is configured to receive the edge of the printed circuit board, wherein the inline connection pads slide into and mate with the board edge connector.
In an analogous device including a handle and dongle field of endeavor, Reddersen teaches such a feature. Reddersen teaches an electronic device (10) comprising a handle assembly including a printed circuit board (20) (Figs. 1-2, Column 2 lines 32-56). Reddersen teaches wherein the printed circuit board (20) has an edge connector (21) comprising a plurality of inline connection pads (edge contacts 22) disposed on its edge (Figs. 1-3, Column 3 lines 17-44). Reddersen further teaches a dongle (38) comprising a board edge connector (30) configured to receive the edge of the printed circuit board (20) and wherein the plurality of inline connection pads (22) of the edge connector (21) slide into and mate with the board edge connector (30) (Figs 1-2, Column 2 lines 32-56, “The first end connector 30 includes tabs 34, 36 which slide into and mate with corresponding slots 24, 26 in the body of the handle of the scanner 10”). As shown in figure 2, the edge connector (21) comprising the plurality of inline connection pads (22) and the dongle comprising the board edge connector (30) are configured to slide into one another and mate (Fig. 2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall in view of Govari to have the printed circuit board (PCB) include a plurality of inline connection pads configured to slide in and mate with a board edge connector of the dongle as taught by Reddersen (Figs. 1-3, Column 2 lines 32-56, Column 3 lines 17-44). The direct mating of the inline connection pads and board edge connector may improve reliability and robustness of the electrical connection. Moreover the inline pads allowing the dongle to mate directly with the PCB edge may result in a slimmer design shown by Reddersen (Fig. 2) which may save vertical space. In addition, this type of electrical interfacing between edge connectors and a corresponding socket or board edge connector is well-known and conventional.
Regarding claim 2, Stigall in view of Govari and Reddersen teaches the invention as claimed above in claim 1.
Stigall further teaches wherein the ultrasonic transducer array (261) corresponds to a micro-electromechanical (MEMS) based Piezoelectric Micromachined Ultrasonic Transducer (pMUT) ([0030], [0053], wherein all piezoelectric micromachined ultrasound transducers are MEMS based).
Regarding claim 3, Stigall in view of Govari and Reddersen teaches the invention as claimed above in claim 1.
Stigall further teaches wherein the ultrasonic catheter (210) comprises a steering control unit positioned within the handle assembly (220), for articulating a distal tip (202) of the ultrasonic catheter (210) and aligning a face of the ultrasonic transducer array (261) towards internal views including an anterior position or a posterior position of a heart ([0003], Stigall teaches conventional/commercial IC catheters can be steered in the heart to acquire images, [0026], Stigall teaches the device 110, 210 can be used to examine the heart or other parts of the heart, [0043-0044], The handle 220 may include actuators 216, a clutch 214, and other steering control components for steering the ultrasound device 210”, “such as within a vessel or other structure within the heart of the patient”, “By controlling the actuators 216 and the clutch 214 on the handle 220, the physician or clinician can steer the flexible elongate member 208 to a position near an area of interest to be imaged. For example, a first actuator 216A may deflect the tip member 202 and the distal portion 204 in a left-right plane and a second actuator 216B may deflect the tip member 202 and the distal portion 204 in an anterior-posterior plane”, “the tip member 202 is used to image or treat the area of interest”, wherein this level of articulation or maneuverability of the distal tip member 202 would allow for alignment of the face the ultrasonic transducer array disposed within the tip towards internal views including an anterior or posterior position of the heart).
Regarding claim 7, Stigall in view of Govari and Reddersen teaches the invention as claimed above in claim 1.
Stigall further teaches wherein the catheter shaft (208) encloses a plurality of individual electronic flex cables connected between the handle assembly (220) and the ultrasonic transducer array (261) (Claim 13, [0009], wherein the flexible elongate member including a first cable and a second cable comprises a plurality of electronic flex cables between the handle assembly and the ultrasonic transducer array, Fig. 5, [0066], wherein the transducer array 261 may include a first and second segment 263, 265, Fig. 2, wherein the flexible elongate member 208 extends from the handle assembly 220 to the tip member 202 including the transducer array).
Regarding claim 17, Stigall teaches an ultrasonic imaging system (200) comprising (Fig. 2, [0043]):
an imaging device (160) configured to receive ultrasound signals (Fig. 2, [0042-0043], [0045], [0066]);
an ultrasonic catheter (210) having a longitudinal axis, a proximal end (206), and a distal end (204) (Fig. 2, [0025], “the ultrasound device 110 is a catheter”, [0043], “In particular, the ultrasound system 200 may have the same functionality as the ultrasound system 100”, [0050]),
the ultrasonic catheter (210) comprising (Fig. 2, [0043-0045]):
a handle assembly (220) (Fig. 2, [0043-0044]);
a catheter shaft (208) connected to the handle assembly (220) at the proximal end (206) (Fig. 2, [0043]);
an ultrasonic transducer array (261) connected to the catheter shaft (208) at the distal end (204) (Figs. 2-3, [0043], [0049], [0051]); and
a dongle (222, 224) communicatively connected to the ultrasonic transducer array (261) and to the imaging device (160), the dongle being configured to communicate the ultrasound signals (Fig. 2, [0045], “These ultrasound echoes may be received by the ultrasound transducer elements, as shown in more detail with reference to FIG. 4. The connector 224 may transfer the received echo signals to the PIM 150 and/or ultrasound processing system 160 where an ultrasound image based on the received echo signals is reconstructed and displayed on the monitor 170”).
However, Stigall fails to teach wherein the handle assembly includes a first printed circuit board; wherein the dongle comprises an interposer with a second printed circuit board; wherein the interposer has a plurality of connector pins extending proximal into the dongle and connected to internal dongle cable connections; and wherein the dongle is coupled to the handle assembly by a connection between the interposer and the first printed circuit board.
In an analogous ultrasonic catheter field of endeavor, Govari teaches such a feature. Govari teaches ultrasonic catheters (22, 50) (Figs. 1 & 2A-2B, [0028-0029], [0034], [0040]). Govari teaches wherein these ultrasonic catheters (22, 50) include a handle (38, 52, 54) (Fig. 1, [0030-0031], “connectors 52 and 54 are mechanically configured to form a sort of ‘split handle’”). Moreover, Govari teaches wherein the handles (38, 52, 54) include a circuit (48, 56) (Figs. 1 & 2A-2B, [0030-0031]). Govari therefore teaches an ultrasonic catheter comprising a handle assembly including a circuit board. Govari further teaches a dongle comprising an adapter (51) configured to connect the catheter (50) to a console (24) (Figs. 1 & 2B, [0006], [0031]). Govari teaches wherein the adapter (51) includes mating receptacles (84) which mate with connector pins (82) of the circuit board (56) of the handle (52) (Fig. 2B, [0034]). Moreover, figure 2b shows wherein the plurality of connector pins (82) are connected to internal dongle cable connections (42) (Fig. 2b). Govari therefore teaches wherein the mating receptacles (84) have a plurality of connector pins (82) extending proximally into the adapter/dongle (51) (see also fig. 2B) and thus teaches wherein the mating receptacles (84) comprise an interposer of the adapter/dongle (51) and wherein the dongle (51) is coupled to the handle assembly (52) by a connection between the interposer (84) and the printed circuit board (56).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall to include a circuit board in the handle, connector pins, and a corresponding adapter for connecting to the circuit board as taught by Govari (Figs. 1 & 2A-2B, [0030-0031], [0034]). It is typical for a circuit to be located in the handle for convenience and the circuit may include controls for steering the catheter as recognized by Govari ([0030]). Moreover, Govari teaches wherein the use of the adapter configured to connect to the catheter may result in reduced cost of the disposable part of a system by allowing for reuse of certain components (i.e. cables and connectors) without sterilization as recognized by Govari ([0031]). Moreover, the use of connector pins and corresponding receptacles in the adapter predictably allow for electrical connection between the adapter (and thus console) and handle and/or transducer array.
However, the modified combination noted above fails to each wherein the first printed circuit board has a plurality of inline connection pads disposed on an edge of the first printed circuit board and wherein the interposer further comprises a board edge connector configured to receive the edge of the first printed circuit board, and wherein the plurality of inline connection pads slides into and mates with the board edge connector.
In an analogous device including a handle and dongle field of endeavor, Reddersen teaches such a feature. Reddersen teaches an electronic device (10) comprising a handle assembly including a printed circuit board (20) (Figs. 1-2, Column 2 lines 32-56). Reddersen teaches wherein the printed circuit board (20) has an edge connector (21) comprising a plurality of inline connection pads (edge contacts 22) disposed on its edge (Figs. 1-3, Column 3 lines 17-44). Reddersen further teaches a dongle (38) comprising a board edge connector (30) configured to receive the edge of the printed circuit board (20) and wherein the plurality of inline connection pads (22) of the edge connector (21) slide into and mate with the board edge connector (30) (Figs 1-2, Column 2 lines 32-56, “The first end connector 30 includes tabs 34, 36 which slide into and mate with corresponding slots 24, 26 in the body of the handle of the scanner 10”). As shown in figure 2, the edge connector (21) comprising the plurality of inline connection pads (22) and the dongle comprising the board edge connector (30) are configured to slide into one another and mate (Fig. 2). Moreover, Reddersen teaches wherein the dongle may include a printed circuit board (50), i.e. a second printed circuit board, therefore wherein the dongle may comprise an interposer with a second printed circuit board (50) (Column 5 lines 23-29).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall in view of Govari to have the printed circuit board (PCB) include a plurality of inline connection pads configured to slide in and mate with a board edge connector of the dongle as taught by Reddersen (Figs. 1-3, Column 2 lines 32-56, Column 3 lines 17-44). The direct mating of the inline connection pads and board edge connector may improve reliability and robustness of the electrical connection. Moreover the inline pads allowing the dongle to mate directly with the PCB edge may result in a slimmer design shown by Reddersen (Fig. 2) which may save vertical space. In addition, this type of electrical interfacing between edge connectors and a corresponding socket or board edge connector is well-known and conventional.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall (US20190053783) in view of Govari (US20070185397) and Reddersen (US5330370) as applied to claim 3 above, and further in view of Sudol (US20220048071). Stigall and Sudol are cited in the IDS filed 01/14/2025.
Regarding claim 4, Stigall in view of Govari and Reddersen teaches the invention as claimed above in claim 3.
However, Stigall fails to teach wherein the distal tip of the ultrasonic catheter is coated with a material to provide electrical isolation and transmission of ultrasound signals.
In an analogous ultrasound probe field of endeavor, Sudol teaches such a feature. Sudol teaches a forward-looking ultrasound probe/catheter (100) (Fig. 1, [0008]). Sudol teaches the tip of the ultrasound probe (100) may be covered in an electrically insulating protective material, e.g. a resin, to protect conductive parts of the tip to exposure to the external environment during internal use of the ultrasound probe (100) ([0009]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall to cover the tip of the ultrasound probe with electrically insulating protective material as taught by Sudol ([0009]). The protective material may protect the tip from the external environment such as bodily fluids during internal use of the ultrasound probe as recognized by Sudol ([0009]). Moreover, the electrically insulating protective material would also obviously be selected to allow for transmission of ultrasound signals as the ultrasound probe would otherwise be inoperable for ultrasound imaging and/or therapy. Therefore, the modification of Stigall with the teachings of Sudol would predictably result in coating the distal tip of the ultrasound catheter with electrically insulative material which provides for both electrical isolation and transmission of ultrasound signals.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall (US20190053783) in view of Govari (US20070185397) and Reddersen (US5330370) as applied to claim 3 above, and further in view of Eaton (US5954654). Stigall and Eaton are cited in the IDS filed 01/14/2025.
Regarding claim 5, Stigall in view of Govari and Reddersen teaches the invention as claimed above in claim 3.
However, Stigall fails to teach wherein the steering control unit comprises a housing enclosing an actuator and a steering hub, and an internal friction occurs between the actuator and the steering hub, and between the actuator and the housing, which causes the ultrasonic catheter to retain its adjusted configuration without operator attention.
In an analogous steerable ultrasonic catheter field of endeavor, Eaton teaches such a feature. Eaton teaches a transducer assembly (200) including a catheter (202), a housing (206) supporting two actuators (208, 210), and two steering hubs (216, 218; 220, 222) (Fig. 7, Column 4 line 65 – Column 5 line 14).
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Eaton teaches friction between the actuators (208, 210) and steering hubs (220, 222) and between the actuators (208, 210) and the housing (206) causes the catheter to retain its adjusted configuration without operator attention (Claim 7, Column 5 lines 28-36, wherein steering rings 208, 210 comprise actuators).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall to have internal friction between the actuator and the steering hub and between the actuator and the housing as taught by Eaton (Claim 7, Column 5 lines 28-36). The friction allows for retention of an adjusted configuration of the steerable catheter without operator attention, which is a desirable feature as recognized by Eaton (Claim 7, “wherein internal friction between the actuator and the steering hub and between the actuator and the housing cause the conduit to retain its adjusted configuration without operator attention”, Column 5 lines 28-36).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall (US20190053783) in view of Govari (US20070185397) and Reddersen (US5330370) as applied to claim 1 above, and further in view of Hastings (US20110257523). Stigall and Hastings are cited in the IDS filed 01/14/2025.
Regarding claim 6, Stigall in view of Govari and Reddersen teaches the invention as claimed above in claim 1.
Stigall further teaches wherein the ultrasonic catheter (210) corresponds to a mechanical flexible sheath (208) to allow passage into a heart (Fig. 2, [0043-0044], wherein flexible elongate member 208 comprises a mechanical flexible sheath, “In operation, a physician or a clinician may advance the flexible elongate member 208 into the anatomy of the patient, such as within a vessel or other structure within the heart of the patient”).
However, Stigall fails to teach wherein the mechanical flexible sheath has a marker band.
In an analogous ultrasonic catheter field of endeavor, Hastings teaches such a feature. Hastings teaches an intravascular imaging catheter (105) including an ultrasonic imaging device (107) (Fig. 19, [0185-0186]).
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Hastings further teaches marker bands may be placed on one or multiple parts of the catheter (105), wherein the marker bands may be platinum or other radiopaque metal ([0193], wherein platinum or other radiopaque metal would form a location on an X-ray image).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall to include marker bands on the catheter as taught by Hastings ([0193]). The marker bands may assist in visualization during delivery, imaging, and/or denervation procedures as recognized by Hastings ([0193]). Stigall modified with the teachings of Hastings would predictably result in the marker bands being disposed on the flexible sheath of the catheter to enable the visualization of the marker bands.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall (US20190053783) in view of Govari (US20070185397) and Reddersen (US5330370) as applied to claim 1 above, and further in view of von Ramm (US20150265245). Stigall and von Ramm are cited in the IDS filed 01/14/2025.
Regarding claim 8, Stigall in view of Govari and Reddersen teaches the invention as claimed above in claim 1.
However, Stigall fails to teach wherein the ultrasound beams transmitted from the plurality of transducer array elements have a bandwidth including a predetermined fundamental mode vibration of each of a plurality of transducer array elements, such that a single array element transmits and receives multiple of the predetermined fundamental mode vibrations simultaneously.
In an analogous ultrasound imaging using pMUT arrays field of endeavor, von Ramm teaches such a feature. Von Ramm teaches an ultrasonic imaging assembly (10) comprising a plurality of pMUT array (13) elements (14) (Fig. 1, [0029]). Von Ramm teaches the plurality of array elements are configured to transmit and receive an ultrasound beam having a bandwidth including a predetermined fundamental mode vibration of each of the plurality of pMUT array elements (Fig. 9, [0010], [0057]). Von Ramm further teaches an array element (48) having four pMUT elements, each having a different vibrational geometry (fundamental frequency) ([0049]). Von Ramm teaches the acoustic energy emitted by the array element (48) will contain a number of different frequencies in the same pulse, allowing for transmission of multiple fundamental mode vibrations simultaneously ([0049]). By transmitting multiple fundamental mode vibrations simultaneously, the elements subsequently receives multiple vibrations simultaneously as von Ramm teaches the array elements are configured to transmit and receive the ultrasound beam having the bandwidth including the predetermined fundamental mode vibration ([0010], [0038], “by employing the fundamental mode vibration of the pMUT 17, acoustic energy is transmitted at a higher efficiency, and can also be more efficiently received when the acoustic energy is reflected back toward the pMUT 17”, [0057]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall to configure the transducer elements to transmit and receive an ultrasound beam having a bandwidth including a predetermined fundamental mode vibration of each transducer element such that the elements transmit and receive multiple fundamental mode vibrations simultaneously as taught by von Ramm (Fig. 9, [0010], [0038], [0049], [0057]). Doing so increases bandwidth and resolution while maintaining beam integrity as recognized by von Ramm ([0049]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall (US20190053783) in view of Govari (US20070185397), Reddersen (US5330370), and von Ramm (US20150265245) as applied to claim 8 above, and further in view of Patil (US20160199030). Stigall, von Ramm, and Patil are cited in the IDS filed 01/14/2025.
Regarding claim 9, Stigall in view of Govari, Reddersen, and von Ramm teaches the invention as claimed above in claim 8.
However, Stigall fails to teach wherein each of the plurality of transducer array elements has transducer cells of multiple diameters to achieve a wide bandwidth.
In an analogous ultrasound imaging using pMUT arrays field of endeavor, von Ramm teaches such a feature. Von Ramm teaches an ultrasonic imaging assembly (10) comprising a plurality of pMUT array (13) elements (14) (Fig. 1, [0029]). Von Ramm teaches transmitting multiple fundamental mode vibrations simultaneously results in increased bandwidth and resolution. Von Ramm teaches the shape of the transducer has an effect on the frequency and bandwidth, and circular shaped pMUTs can be used to form a variety of different array elements, thereby increasing overall array bandwidth ([0049]). Von Ramm teaches it may be desirable to group multiple pMUTs having different sizes together ([0048]) and any number of pMUT shapes and sizes may be employed in different elements as desired ([0053]). Von Ramm lastly teaches the geometry of each pMUT dictates the fundamental mode vibration for the pMUT ([0008], [0026], [0030]). Von Ramm therefore teaches grouping of different transducer array elements (pMUTs) having different shapes and sizes to achieve a wider bandwidth.
Patil, whom also teaches ultrasonic imaging systems (Abstract), teaches a transducer array comprising two pluralities of transducer cells that have different diameters (Fig. 12b, [0071]). Patil teaches the different diameters results in different frequency sensitivities (fundamental mode vibration). ([0071]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall to have each transducer cell have different diameters as taught by von Ramm ([0026], [0048-0049], [0053]) and Patil ([0071]). Von Ramm teaches the geometry of each pMUT dictates the fundamental mode vibration for the pMUT ([0026]) and transmitting multiple fundamental mode vibrations simultaneously results in increased bandwidth and resolution ([0049]). By grouping of different transducer array elements (pMUTs) having different shapes and sizes, multiple fundamental mode vibrations may be transmitted resulting in increased bandwidth and resolution. Patil teaches having transducer cells of different diameters results in different frequencies for each transducer. Therefore it’d be obvious to use transducer cells of multiple different diameters as it would result in transmission of multiple fundamental mode vibrations and increased bandwidth and resolution as taught by von Ramm and Patil.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall (US20190053783) in view of Govari (US20070185397) and Reddersen (US5330370) as applied to claim 1 above, and further in view of Harhen (US20060235304). Stigall is cited in the IDS filed 01/14/2025.
Regarding claim 10, Stigall in view of Govari and Reddersen teaches the invention as claimed above in claim 1.
Stigall teaches wherein the ultrasonic catheter (210) includes steering control components in the handle assembly (220) for steering ([0043-0044]).
However, Stigall fails to explicitly teach wherein the catheter shaft comprises a plurality of steering cables that is connected to the printed circuit board.
In an analogous ultrasound probe field of endeavor, Harhen teaches such a feature. Harhen teaches an ultrasound probe including a transducer assembly (60) and a handle (84) ([0019]). Harhen teaches wherein the handle (84) includes a first connector (90) which includes a first electrical interface (94) configured to mate with a second electrical interface (74) (Figs. 2 & 4, [0022]). Harhen teaches wherein the probe has a plurality of pull wires (65) which extend through the probe shaft (62) (Figs. 7-9, [0030]). As shown in figure 9, the second electrical interface (74) comprising a circuit board of the handle is connected to the plurality of pull wires (65) via pins. Harhen further teaches wherein a circuit is operatively connected to the second electrical interface (Claim 15, [0029]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall to have the steering components such as pull wires be connected to the printed circuit board as taught by Harhen (Figs. 7-9, Claim 15, [0029-0030]). By having the pull wires be closely connected to the circuit board, the actuators near the circuit may cause movement of the pull wires to facilitate bending as recognized by Harhen (Fig. 9, [0029-0030]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall (US20190053783) in view of Govari (US20070185397) and Reddersen (US5330370) as applied to claim 1 above, and further in view of Sliwa (US20100168569) and Cuscuna (US20220225960). Stigall is cited in the IDS filed 01/14/2025.
Regarding claim 11, Stigall in view of Govari and Reddersen teaches the invention as claimed above in claim 1.
Stigall teaches wherein the ultrasonic catheter (210) includes steering control components in the handle assembly (220) for steering ([0043-0044]).
However, Stigall fails to explicitly teach wherein the catheter shaft comprises a plurality of steering cables that is connected to the ultrasonic transducer array.
In an analogous ultrasonic catheter field of endeavor, Sliwa and Cuscuna teaches such a feature. Sliwa teaches a surgical tool (12) comprising an ultrasonic catheter with an elongate shaft (20), a handle (22), and an ultrasound imaging transducer (26) (Figs. 1-2, [0037-0038]). Sliwa teaches wherein the elongate shaft includes a lumen (36) configured to have pull wires (60) ([0039], [0050]). Sliwa teaches the pull wire (60) is coupled to and between an activation knob (58) and the ultrasound imaging transducer (26) (Figs. 2-4, [0050]). Sliwa teaches the pull wire (60) is affixed or attached to a flange (62) on or associated with the ultrasound imaging transducer (Figs. 4a-4b, [0050]).
Cuscuna similarly teaches a steerable catheter including a transducer (Abstract). Cuscuna teaches wherein a plurality of pull-cables may be used to facilitate bending (Abstract, [0007]). Sliwa and Cuscuna therefore teach a catheter shaft comprising a plurality of steering cable that is connected to the ultrasonic transducer array.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall to include a plurality of pull wires in the shaft connected to the ultrasound transducer as taught by Sliwa (Figs. 4a-4b, [0050]) and Cuscuna (Abstract, [0007]). Connecting the pull-cables to the transducer predictably allows for manipulation of the orientation of the transducer to acquire images. Having the pull wires extend from the handle through the shaft to the transducer allows for actuators/knobs located at the handle to control the orientation of the transducer at the distal end as recognized by Sliwa ([0050]). Moreover, by using a plurality of pull-wires, more degrees of freedom of movement may be provided as recognized by Cuscuna ([0007]).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Stigall (US20190053783) in view of Govari (US20070185397), Holdaway (US20010047134), and Reddersen (US5330370). Stigall is cited in the IDS filed 01/14/2025.
Regarding claim 12, Stigall teaches an ultrasonic catheter (210) configured for use with an ultrasonic imaging system (200), the ultrasonic catheter (210) having a longitudinal axis, a proximal end (206), and a distal end (204), the ultrasonic catheter comprising (Fig. 2, [0025], “the ultrasound device 110 is a catheter”, [0043], “In particular, the ultrasound system 200 may have the same functionality as the ultrasound system 100”, [0050]):
a handle assembly (220) (Fig. 2, [0043-0044]);
a catheter shaft (208) to the handle assembly (220) at the proximal end (206) (Fig. 2, [0043]);
a first ultrasonic transducer array (261; 263) connected to the catheter shaft (208) at the distal end (204) (Figs. 2-3 & 5, [0043], [0049], [0051], [0056]);
an electronic flex cable position in the catheter shaft (208) and communicatively connected to the first ultrasonic transducer array (261) and configured to transmit ultrasound signals (Claim 13, [0008-0009], wherein the flexible elongate member including a first cable and a second cable comprises an electronic flex cable positioned in the catheter shaft, Fig. 5, [0063], [0066]).
However, Stigall fails to teach wherein the handle assembly includes a printed circuit board, the printed circuit board being configured to be communicatively connected to an imaging device that is configured to receive ultrasound signals.
In an analogous ultrasonic catheter field of endeavor, Govari teaches such a feature. Govari teaches ultrasonic catheters (22, 50) (Figs. 1 & 2A-2B, [0028-0029], [0034], [0040]). Govari teaches wherein these ultrasonic catheters (22, 50) include a handle (38, 52, 54) (Fig. 1, [0030-0031], “connectors 52 and 54 are mechanically configured to form a sort of ‘split handle’”). Moreover, Govari teaches wherein the handles (38, 52, 54) include a circuit (48, 56) (Figs. 1 & 2A-2B, [0030-0031]). Govari therefore teaches an ultrasonic catheter comprising a handle assembly including a circuit board. Govari further teaches wherein the circuits (48, 56) are communicatively connected to a console (24) having a display (44) via a cable (Figs. 1 & 2A-2B, [0030-0033]). Moreover, Govari teaches wherein the invention (catheter) may include an ultrasonic imaging transducer and circuitry provided therefor ([0040]). Govari therefore teaches a printed circuit board, the printed circuit board configured to be communicatively connected to a console (24) or an imaging device that is configured to receive ultrasound signals; Stigall teaches wherein the console is an imaging device (160, 200) configured to receive ultrasound signals ([0045]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall to include a circuit board in the handle and have the circuit board be connected to the imaging system as taught by Govari (Figs. 1 & 2A-2B, [0030-0031], [0034]). It is typical for a circuit to be located in the handle for convenience and the circuit may include controls for steering the catheter as recognized by Govari ([0030]). Moreover, positioning and/or ultrasound signals may predictably be transmitted from the circuit board to the imaging device for processing and display as further recognized by Govari ([0030]). In addition, since Stigall teaches wherein the console is an imaging device (160, 200) configured to receive ultrasound signals (Fig. 2, [0045]), Stigall modified by Govari would predictably result in the printed circuit board that is connected to a console to be configured to be communicatively connected to the console comprising the imaging device (160, 200) of Stigall that is configured to receive ultrasound signals.
However, the modified combination noted above fails to teach wherein the electronic flex cable is connected to a common ground for the first ultrasonic transducer array.
In an analogous ultrasound imaging probe field of endeavor, Holdaway teaches such a feature. Holdaway teaches first and second ultrasound transducers (64’, 64”) within a flexible shaft or sheath (50’) (Fig. 2, [0045], [0066]). Holdaway teaches the flexible shaft (50) includes a common ground conductor (62’) which serves as ground for both transducers 64’ and 64” (Fig. 2, [0066]). Holdaway further teaches signal conductors (54’, 54”) configured to conduct signals from transducers 62’ and 64” respectively (Fig. 2, [0066], wherein the signal conductors comprise an electronic flex cable). As shown in figure 2, the electronic flex cable(s) (54’, 54”) are connected to common ground (62’) via the transducers (64’, 64”). Moreover, Holdaway teaches wherein the ultrasound transducers (64’, 64”) are configured for ultrasound imaging ([0066], [0083]). Holdaway therefore teaches an electronic flex cable (54’) connected to a common ground (62’) for a first transducer (64’) (Fig. 2, [0066]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall to include a common ground line for the transducers as taught by Holdaway (Fig. 2, [0066]). The common ground may serve as a reference point for voltage and also a return path for current.
However, the modified combination noted above fails to teach wherein the printed circuit board has a plurality of inline connection pads disposed on an edge of the printed circuit board.
In an analogous device including a handle and dongle field of endeavor, Reddersen teaches such a feature. Reddersen teaches an electronic device (10) comprising a handle assembly including a printed circuit board (20) (Figs. 1-2, Column 2 lines 32-56). Reddersen teaches wherein the printed circuit board (20) has an edge connector (21) comprising a plurality of inline connection pads (edge contacts 22) disposed on its edge (Figs. 1-3, Column 3 lines 17-44). Reddersen further teaches a dongle (38) comprising a board edge connector (30) configured to receive the edge of the printed circuit board (20) and wherein the plurality of inline connection pads (22) of the edge connector (21) slide into and mate with the board edge connector (30) (Figs 1-2, Column 2 lines 32-56, “The first end connector 30 includes tabs 34, 36 which slide into and mate with corresponding slots 24, 26 in the body of the handle of the scanner 10”). As shown in figure 2, the edge connector (21) comprising the plurality of inline connection pads (22) and the dongle comprising the board edge connector (30) are configured to slide into one another and mate (Fig. 2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall in view of Govari to have the printed circuit board (PCB) include a plurality of inline connection pads configured to slide in and mate with a board edge connector of a dongle as taught by Reddersen (Figs. 1-3, Column 2 lines 32-56, Column 3 lines 17-44). The direct mating of the inline connection pads and board edge connector may improve reliability and robustness of the electrical connection. Moreover the inline pads allowing the dongle to mate directly with the PCB edge may result in a slimmer design shown by Reddersen (Fig. 2) which may save vertical space. In addition, this type of electrical interfacing between edge connectors and a corresponding socket or board edge connector is well-known and conventional.
Regarding claim 13, Stigall in view of Govari, Holdaway, and Reddersen teaches the invention as claimed above in claim 12.
Stigall teaches the invention further comprising a second ultrasonic transducer array (265) connected to the distal end of the catheter shaft (208) (Figs. 3 & 5, [0056], wherein the second segment 265 of the transducer array 261 comprises a second ultrasonic transducer array, [0060], “…second segment 265 may include one or more subarrays of transducer elements 420”), wherein the second ultrasonic transducer array (265) is communicatively connected to the electronic flex cable (410) in parallel to the first ultrasonic transducer array (261) (Fig. 4, [0061], wherein each transducer element being separately coupled to the coaxial cable 410 results in the two arrays 261 265 being connected to the cable 410 in parallel; see figure 4).
However, Stigall fails to teach wherein the second ultrasonic transducer array is communicatively connected to the electronic flex cable in series to the common ground.
In an analogous ultrasound imaging probe field of endeavor, Holdaway teaches such a feature. Holdaway teaches first and second ultrasound transducers (64’, 64”) within a flexible shaft or sheath (50’) (Fig. 2, [0045], [0066]). Holdaway teaches wherein the first and second transducers include respective signal conductors (54’, 54”) for conducting electrical signals (Fig. 2, [0066], wherein the signal conductors comprise electronic flex cables). Holdaway further teaches the flexible shaft (50) includes a common ground conductor (62’) which serves as ground for both transducers 64’ and 64” (Fig. 2, [0066]). As shown in figure 2 of Holdaway, the second ultrasonic transducer (64”) is connected to the electronic flex cable (54”) in series with common ground (62’) (Fig. 2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall to have the second ultrasound transducer be connected to the electronic flex cable in series with common ground as taught by Holdaway (Fig. 2, [0066]). Having the transducer be connected in series between common ground and the electronic flex cable allows for voltage potential to be applied across the transducer to drive/power the transducer. Moreover, the ground line may act as a return path for the signal current.
Regarding claim 14, Stigall in view of Govari, Holdaway, and Reddersen teaches the invention as claimed above in claim 12.
Stigall teaches the invention further comprising a dongle (224, 224), the dongle (222, 224) being communicatively connected to the first ultrasonic transducer array (261; 263) (Fig. 2, [0043-0045]) and configured to be communicatively connected to the imaging device (160, 200) to communicate the ultrasound signals (Fig. 2, [0045], “These ultrasound echoes may be received by the ultrasound transducer elements, as shown in more detail with reference to FIG. 4. The connector 224 may transfer the received echo signals to the PIM 150 and/or ultrasound processing system 160 where an ultrasound image based on the received echo signals is reconstructed and displayed on the monitor 170”).
However, Stigall fails to teach wherein the dongle comprises a board edge connector that is connected to the printed circuit board.
In an analogous device including a handle and dongle field of endeavor, Reddersen teaches such a feature. Reddersen teaches an electronic device (10) comprising a handle assembly including a printed circuit board (20) (Figs. 1-2, Column 2 lines 32-56). Reddersen teaches wherein the printed circuit board (20) has an edge connector (21) comprising a plurality of inline connection pads (edge contacts 22) disposed on its edge (Figs. 1-3, Column 3 lines 17-44). Reddersen further teaches a dongle (38) comprising a board edge connector (30) configured to receive the edge of the printed circuit board (20) and wherein the plurality of inline connection pads (22) of the edge connector (21) slide into and mate with the board edge connector (30) (Figs 1-2, Column 2 lines 32-56, “The first end connector 30 includes tabs 34, 36 which slide into and mate with corresponding slots 24, 26 in the body of the handle of the scanner 10”). As shown in figure 2, the edge connector (21) comprising the plurality of inline connection pads (22) and the dongle comprising the board edge connector (30) are configured to slide into one another and mate (Fig. 2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall in view of Govari to have the dongle comprise a board edge connector configured to mate with the inline connection pads of the printed circuit board as taught by Reddersen (Figs. 1-3, Column 2 lines 32-56, Column 3 lines 17-44). The direct mating of the inline connection pads and a board edge connector may improve reliability and robustness of the electrical connection. Moreover the inline pads and board edge connector enabling the dongle to mate directly with the PCB edge may result in a slimmer design shown by Reddersen (Fig. 2) which may save vertical space. In addition, this type of electrical interfacing between edge connectors and a corresponding socket or board edge connector is well-known and conventional.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall (US20190053783) in view of Govari (US20070185397), Holdaway (US20010047134), and Reddersen (US5330370) as applied to claim 14 above, and further in view of Sliwa (US20100168569) and Cuscuna (US20220225960). Stigall is cited in the IDS filed 01/14/2025.
Regarding claim 15, Stigall in view of Govari, Holdaway, and Reddersen teaches the invention as claimed above in claim 14.
Stigall teaches wherein the ultrasonic catheter (210) includes steering control components in the handle assembly (220) for steering ([0043-0044]).
However, Stigall fails to explicitly teach wherein the catheter shaft comprises a plurality of steering cables that is connected to the first ultrasonic transducer array.
In an analogous ultrasonic catheter field of endeavor, Sliwa and Cuscuna teaches such a feature. Sliwa teaches a surgical tool (12) comprising an ultrasonic catheter with an elongate shaft (20), a handle (22), and an ultrasound imaging transducer (26) (Figs. 1-2, [0037-0038]). Sliwa teaches wherein the elongate shaft includes a lumen (36) configured to have pull wires (60) ([0039], [0050]). Sliwa teaches the pull wire (60) is coupled to and between an activation knob (58) and the ultrasound imaging transducer (26) (Figs. 2-4, [0050]). Sliwa teaches the pull wire (60) is affixed or attached to a flange (62) on or associated with the ultrasound imaging transducer (Figs. 4a-4b, [0050]).
Cuscuna similarly teaches a steerable catheter including a transducer (Abstract). Cuscuna teaches wherein a plurality of pull-cables may be used to facilitate bending (Abstract, [0007]). Sliwa and Cuscuna therefore teach a catheter shaft comprising a plurality of steering cable that is connected to the ultrasonic transducer array.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall to include a plurality of pull wires in the shaft connected to the ultrasound transducer as taught by Sliwa (Figs. 4a-4b, [0050]) and Cuscuna (Abstract, [0007]). Connecting the pull-cables to the transducer predictably allows for manipulation of the orientation of the transducer to acquire images. Having the pull wires extend from the handle through the shaft to the transducer allows for actuators/knobs located at the handle to control the orientation of the transducer at the distal end as recognized by Sliwa ([0050]). Moreover, by using a plurality of pull-wires, more degrees of freedom of movement may be provided as recognized by Cuscuna ([0007]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall (US20190053783) in view of Govari (US20070185397), Holdaway (US20010047134), Reddersen (US5330370), Sliwa (US20100168569), and Cuscuna (US20220225960) as applied to claim 15 above, and further in view of Harhen (US20060235304). Stigall is cited in the IDS filed 01/14/2025.
Regarding claim 16, Stigall in view of Govari, Holdaway, Reddersen, Sliwa, and Cuscuna teaches the invention as claimed above in claim 15.
Stigall teaches wherein the ultrasonic catheter (210) includes steering control components in the handle assembly (220) for steering ([0043-0044]).
However, Stigall fails to explicitly teach wherein the plurality of steering cables that is connected to the printed circuit board.
In an analogous ultrasound probe field of endeavor, Harhen teaches such a feature. Harhen teaches an ultrasound probe including a transducer assembly (60) and a handle (84) ([0019]). Harhen teaches wherein the handle (84) includes a first connector (90) which includes a first electrical interface (94) configured to mate with a second electrical interface (74) (Figs. 2 & 4, [0022]). Harhen teaches wherein the probe has a plurality of pull wires (65) which extend through the probe shaft (62) (Figs. 7-9, [0030]). As shown in figure 9, the second electrical interface (74) comprising a circuit board of the handle is connected to the plurality of pull wires (65) via pins. Harhen further teaches wherein a circuit is operatively connected to the second electrical interface (Claim 15, [0029]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall to have the steering components such as pull wires be connected to the printed circuit board as taught by Harhen (Figs. 7-9, Claim 15, [0029-0030]). By having the pull wires be closely connected to the circuit board, the actuators near the circuit may cause movement of the pull wires to facilitate bending as recognized by Harhen (Fig. 9, [0029-0030]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall (US20190053783) in view of Govari (US20070185397) and Reddersen (US5330370) as applied to claim 17 above, and further in view of Harhen (US20060235304). Stigall is cited in the IDS filed 01/14/2025.
Regarding claim 19, Stigall in view of Govari and Reddersen teaches the invention as claimed above in claim 17.
Stigall teaches wherein the ultrasonic catheter (210) includes steering control components in the handle assembly (220) for steering ([0043-0044]).
However, Stigall fails to explicitly teach wherein the catheter shaft comprises a plurality of steering cables that is connected to the circuit board.
In an analogous ultrasound probe field of endeavor, Harhen teaches such a feature. Harhen teaches an ultrasound probe including a transducer assembly (60) and a handle (84) ([0019]). Harhen teaches wherein the handle (84) includes a first connector (90) which includes a first electrical interface (94) configured to mate with a second electrical interface (74) (Figs. 2 & 4, [0022]). Harhen teaches wherein the probe has a plurality of pull wires (65) which extend through the probe shaft (62) (Figs. 7-9, [0030]). As shown in figure 9, the second electrical interface (74) comprising a circuit board of the handle is connected to the plurality of pull wires (65) via pins. Harhen further teaches wherein a circuit is operatively connected to the second electrical interface (Claim 15, [0029]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall to have the steering components such as pull wires be connected to the circuit board as taught by Harhen (Figs. 7-9, Claim 15, [0029-0030]). By having the pull wires be closely connected to the circuit board, the actuators near the circuit may cause movement of the pull wires to facilitate bending as recognized by Harhen (Fig. 9, [0029-0030]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall (US20190053783) in view of Govari (US20070185397) and Reddersen (US5330370) as applied to claim 17 above, and further in view of Sliwa (US20100168569) and Cuscuna (US20220225960). Stigall is cited in the IDS filed 01/14/2025.
Regarding claim 20, Stigall in view of Govari and Reddersen teaches the invention as claimed above in claim 17.
Stigall teaches wherein the ultrasonic catheter (210) includes steering control components in the handle assembly (220) for steering ([0043-0044]).
However, Stigall fails to explicitly teach wherein the catheter shaft comprises a plurality of steering cables that is connected to the ultrasonic transducer array.
In an analogous ultrasonic catheter field of endeavor, Sliwa and Cuscuna teaches such a feature. Sliwa teaches a surgical tool (12) comprising an ultrasonic catheter with an elongate shaft (20), a handle (22), and an ultrasound imaging transducer (26) (Figs. 1-2, [0037-0038]). Sliwa teaches wherein the elongate shaft includes a lumen (36) configured to have pull wires (60) ([0039], [0050]). Sliwa teaches the pull wire (60) is coupled to and between an activation knob (58) and the ultrasound imaging transducer (26) (Figs. 2-4, [0050]). Sliwa teaches the pull wire (60) is affixed or attached to a flange (62) on or associated with the ultrasound imaging transducer (Figs. 4a-4b, [0050]).
Cuscuna similarly teaches a steerable catheter including a transducer (Abstract). Cuscuna teaches wherein a plurality of pull-cables may be used to facilitate bending (Abstract, [0007]). Sliwa and Cuscuna therefore teach a catheter shaft comprising a plurality of steering cable that is connected to the ultrasonic transducer array.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Stigall to include a plurality of pull wires in the shaft connected to the ultrasound transducer as taught by Sliwa (Figs. 4a-4b, [0050]) and Cuscuna (Abstract, [0007]). Connecting the pull-cables to the transducer predictably allows for manipulation of the orientation of the transducer to acquire images. Having the pull wires extend from the handle through the shaft to the transducer allows for actuators/knobs located at the handle to control the orientation of the transducer at the distal end as recognized by Sliwa ([0050]). Moreover, by using a plurality of pull-wires, more degrees of freedom of movement may be provided as recognized by Cuscuna ([0007]).
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 TOMMY T LY whose telephone number is (571) 272-6404. The examiner can normally be reached M-F 12:00pm-8:00pm eastern time.
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/TOMMY T LY/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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