DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This action is in response to the amendments and remarks filed on 04/21/2020. The amendments filed on 08/25/2026 have been entered. Accordingly Claims 1-12, 15-17 and 19-25 are pending. Claims 13-14 and 18 are cancled. The previous objections and rejections have been withdrawn in light of Applicant’s amendments and remarks in the claim set filed 08/25/2026.
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.
Claim 12 is 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 12, claim dependency is unclear. The amended claim 12 has removed dependency from claim 9 but not established current claim dependency. Examiner for the purpose of Examination will consider claim 12 dependent from claim 1.
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, 7-12, 15-17 and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Cannata et. al. (U.S. 20200164231, May 28, 2020)(hereinafter, “Cannata”) in view of Sihalla (U.S. 20080295615, December 4, 2008)(hereinafter, “Sihalla”).
Regarding Claim 1, Cannata teaches: An ultrasound treatment head (Fig. 1A, [0087][0094]. See Fig. 1A), comprising:
a therapy transducer array including an opening (“… histotripsy system 100...comprising a therapy transducer 102…” [0094]. See reproduced Fig. 1A below);
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With regards to limitations: a coupling assembly disposed within the opening of the therapy transducer array and coupled to the therapy transducer array, the coupling assembly configured to receive an imaging probe, the coupling assembly further including one or more vents configured to displace air bubbles from a distal surface of the therapy transducer array and the coupling assembly when the treatment head is submerged in a fluid (“The patient coupling system can comprise a six degree of freedom, six joint, mechanical arm, configured with a mounting bracket designed to interface to a surgical/interventional table rail… The frame is also configured, in a sealed system, to allow two-way fluid communication between the ultrasound medium container and an ultrasound medium source (e.g. reservoir or fluidics management system), including, but not limited for filling and draining, as well as air venting for bubble management.” [0092];“FIG. 1A generally illustrates histotripsy system 100…comprising a therapy transducer 102, an imaging system 104…The system can further include an ultrasound coupling interface and a source of coupling medium…” [0094]; “ The rear panel of the cart can comprise air inlet vents to direct airflow to air exhaust vents located in the side, top and bottom panels. The side panels of the cart include a holster and support mechanism for holding the handheld imaging probe. The base of the cart can be comprised of a cast base interfacing with the rack mounted electronics and providing an interface to the side panels and top cover.” [0088]).
Cannata does not explicitly teach the coupling assembly further including one or more vents.
Sihalla in the field of water sensing based systems teaches: “FIG. 2 illustrates a sensing device 201, circuit board 211, probes 205, 207 and 209 and connecting electrical cable 213. The device 201 is shown deployed below water level 203… A sample or sampling chamber 222 is shown connected to the lower portion of the sensing device 201 and placed so as to enclose the probes 205, 207 and 209 of the device 201 within the sampling chamber 222. The sampling chamber is totally water-sealed from the surrounding water and from the water sensing device 201 and the lower sections of the module 221, except for a water inlet 247 for allowing water to flow into the chamber 222, and a water outlet 248 for allowing water to be evacuated from the chamber 222 at the proper times as is hereinafter explained in greater detail. The sampling chamber 222 also has an air vent 252 which is allowed to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222. A second or component section 229 of the sampling module 221 contains a valve device 233, a pump 235 and a circuit board 231. The second section is also water sealed from the surrounding water. A third section 239 of the sampling module 221 is open to surrounding water at the bottom and through holes 242. The third section 239 acts as an interface to the surrounding water to selectively allow water to enter the sampling module through the filter material 241.” [0020-0021].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the coupling assembly of Cannata to include one or more vents as taught in Sihalla allowing “…to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222.” (Sihalla, [0021]), for the intended purpose of displacing air bubbles from a distal surface of the therapy transducer array and the coupling assembly when the treatment head is submerged in a fluid.
Regarding Claim 2, the combination of Cannata and Sihalla teach the claim limitations as noted above.
Cannata further teaches: wherein the coupling assembly is generally cylindrically shaped (“FIG. 1A generally illustrates histotripsy system 100…comprising a therapy transducer 102, an imaging system 104…The system can further include an ultrasound coupling interface and a source of coupling medium…” [0094]; “ The reservoir or medium container may be formed and shaped to adapt/conform to the patient, allow the therapy transducer to engage and work within the acoustic medium, per defined and required working space… The container may be of various shapes, sizes, curvatures, and dimensions, and may be comprised of a variety of materials…” [0174]. See reproduced Fig. 1A above.).
Regarding Claim 3, the combination of Cannata and Sihalla teach the claim limitations as noted above.
Cannata further teaches: wherein the coupling assembly includes a distal portion configured to receive the imaging probe (“FIG. 1A generally illustrates histotripsy system 100…comprising a therapy transducer 102, an imaging system 104…The system can further include an ultrasound coupling interface and a source of coupling medium…” [0094]; “FIG. 1B is a bottom view of the therapy transducer 102 and the imaging system 104. As shown, the imaging system can be positioned in the center of the therapy transducer.”. See reproduced Fig. 1A above and Fig. 1B).
Regarding Claim 4, the combination of Cannata and Sihalla teach the claim limitations as noted above.
Cannata further teaches: “The patient coupling system can comprise a six degree of freedom, six joint, mechanical arm, configured with a mounting bracket designed to interface to a surgical/interventional table rail… The frame is also configured, in a sealed system, to allow two-way fluid communication between the ultrasound medium container and an ultrasound medium source (e.g. reservoir or fluidics management system), including, but not limited for filling and draining, as well as air venting for bubble management.” [0092].
Cannata does not explicitly teach wherein the one or more vents are disposed on the distal portion.
Sihalla in the field of water sensing based systems teaches “FIG. 2 illustrates a sensing device 201, circuit board 211, probes 205, 207 and 209 and connecting electrical cable 213. The device 201 is shown deployed below water level 203… A sample or sampling chamber 222 is shown connected to the lower portion of the sensing device 201 and placed so as to enclose the probes 205, 207 and 209 of the device 201 within the sampling chamber 222. The sampling chamber is totally water-sealed from the surrounding water and from the water sensing device 201 and the lower sections of the module 221, except for a water inlet 247 for allowing water to flow into the chamber 222, and a water outlet 248 for allowing water to be evacuated from the chamber 222 at the proper times as is hereinafter explained in greater detail. The sampling chamber 222 also has an air vent 252 which is allowed to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222. A second or component section 229 of the sampling module 221 contains a valve device 233, a pump 235 and a circuit board 231. The second section is also water sealed from the surrounding water. A third section 239 of the sampling module 221 is open to surrounding water at the bottom and through holes 242. The third section 239 acts as an interface to the surrounding water to selectively allow water to enter the sampling module through the filter material 241.” [0020-0021].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the one or more vents in the combination of references to be disposed on the distal portion as taught in Sihalla allowing “…to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222.” (Sihalla, [0021]).
Regarding Claim 7, the combination of Cannata and Sihalla teach the claim limitations as noted above.
Cannata does not explicitly teach wherein one or more of the vents are configured to displace air bubbles from the distal surface, through the coupling assembly, and out of a proximal portion of the coupling assembly.
Sihalla in the field of water sensing based systems teaches “FIG. 2 illustrates a sensing device 201, circuit board 211, probes 205, 207 and 209 and connecting electrical cable 213. The device 201 is shown deployed below water level 203… A sample or sampling chamber 222 is shown connected to the lower portion of the sensing device 201 and placed so as to enclose the probes 205, 207 and 209 of the device 201 within the sampling chamber 222. The sampling chamber is totally water-sealed from the surrounding water and from the water sensing device 201 and the lower sections of the module 221, except for a water inlet 247 for allowing water to flow into the chamber 222, and a water outlet 248 for allowing water to be evacuated from the chamber 222 at the proper times as is hereinafter explained in greater detail. The sampling chamber 222 also has an air vent 252 which is allowed to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222. A second or component section 229 of the sampling module 221 contains a valve device 233, a pump 235 and a circuit board 231. The second section is also water sealed from the surrounding water. A third section 239 of the sampling module 221 is open to surrounding water at the bottom and through holes 242. The third section 239 acts as an interface to the surrounding water to selectively allow water to enter the sampling module through the filter material 241.” [0020-0021].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the one or more vents in the combination of references to be configured to displace air bubbles from the distal surface, through the coupling assembly, and out of a proximal portion of the coupling assembly as taught in Sihalla allowing “…to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222.” (Sihalla, [0021]).
Regarding Claim 8, the combination of Cannata and Sihalla teach the claim limitations as noted above.
Cannata further teaches: further comprising one or more channels disposed along at least a portion of a longitudinal length of the coupling assembly (“The reservoir or medium container may be formed and shaped to adapt/conform to the patient, allow the therapy transducer to engage and work within the acoustic medium, per defined and required working space... and wherein said reservoir or medium container may also mechanically support the load, and distribution of the load, through the use of a mechanical and/or electromechanical support structure…it may comprise features such as films, drapes, membranes, bellows, etc. that may be insertable and removable, and/or fabricated within. It may further contain various sensors, drains, lighting (e.g., LEDs), markings, text, etc.” [0174]; “the membrane and/or film may comprise an opening, the edge of which affords mechanical sealing to the patient, but in contrast allows medium communication with the patient…The superstructure of the reservoir or medium container in both these examples may further afford the proximal portion of the structure (e.g., top) to be open or enclosed…”[0175]).
Regarding Claim 9, the combination of Cannata and Sihalla teach the claim limitations as noted above.
With regards to limitation: wherein the one or more channels are fluidly coupled to the one or more vents on the distal portion of the coupling assembly, Cannata further teaches: “The reservoir or medium container may be formed and shaped to adapt/conform to the patient, allow the therapy transducer to engage and work within the acoustic medium, per defined and required working space... and wherein said reservoir or medium container may also mechanically support the load, and distribution of the load, through the use of a mechanical and/or electromechanical support structure…it may comprise features such as films, drapes, membranes, bellows, etc. that may be insertable and removable, and/or fabricated within. It may further contain various sensors, drains, lighting (e.g., LEDs), markings, text, etc.” [0174]; “the membrane and/or film may comprise an opening, the edge of which affords mechanical sealing to the patient, but in contrast allows medium communication with the patient…The superstructure of the reservoir or medium container in both these examples may further afford the proximal portion of the structure (e.g., top) to be open or enclosed…”[0175].
Cannat does not explicitly teach the coupling assembly further including one or more vents.
Sihalla in the field of water sensing based systems teaches: “FIG. 2 illustrates a sensing device 201, circuit board 211, probes 205, 207 and 209 and connecting electrical cable 213. The device 201 is shown deployed below water level 203… A sample or sampling chamber 222 is shown connected to the lower portion of the sensing device 201 and placed so as to enclose the probes 205, 207 and 209 of the device 201 within the sampling chamber 222. The sampling chamber is totally water-sealed from the surrounding water and from the water sensing device 201 and the lower sections of the module 221, except for a water inlet 247 for allowing water to flow into the chamber 222, and a water outlet 248 for allowing water to be evacuated from the chamber 222 at the proper times as is hereinafter explained in greater detail. The sampling chamber 222 also has an air vent 252 which is allowed to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222. A second or component section 229 of the sampling module 221 contains a valve device 233, a pump 235 and a circuit board 231. The second section is also water sealed from the surrounding water. A third section 239 of the sampling module 221 is open to surrounding water at the bottom and through holes 242. The third section 239 acts as an interface to the surrounding water to selectively allow water to enter the sampling module through the filter material 241.” [0020-0021].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the coupling assembly of Cannata to include one or more vents as taught in Sihalla allowing “…to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222.” (Sihalla, [0021]), for the intended purpose of displacing air bubbles from a distal surface of the therapy transducer array and the coupling assembly when the treatment head is submerged in a fluid.
Regarding Claim 10, the combination of Cannata and Sihalla teach the claim limitations as noted above.
Cannata further teaches: wherein the one or more channels are configured to direct the air bubbles into a cavity of the coupling assembly (“The patient coupling system can comprise a six degree of freedom, six joint, mechanical arm, configured with a mounting bracket designed to interface to a surgical/interventional table rail… The frame is also configured, in a sealed system, to allow two-way fluid communication between the ultrasound medium container and an ultrasound medium source (e.g. reservoir or fluidics management system), including, but not limited for filling and draining, as well as air venting for bubble management.” [0092]; “Enclosed iterations of the reservoir or medium container may comprise various features for sealing, in some embodiments sealing to a proximal/top portion or structure of a reservoir/container, or in other cases where sealing may comprise embodiments that seal to the transducer, or a feature on the transducer housings. Further, some embodiments may comprise the dynamic ability to control the volume of fluid within these designs, to minimize the potential for air bubbles or turbulence in said fluid. As such, integrated features allowing fluid communication, and control of, may be provided (ability to provide/remove fluid on demand), including the ability to monitor and control various fluid parameters… the overall system, and as part, the Coupling sub-system, may comprise a fluid conditioning system, which may contain various electromechanical devices, systems, power, sensing, computing and control systems, etc.” [0179]).
Regarding Claim 11, the combination of Cannata and Sihalla teach the claim limitations as noted above.
With regards to limitation: wherein the one or more channels are configured to direct the air bubbles towards one or more vents on a proximal portion of the coupling assembly, Cannata further teaches: “The patient coupling system can comprise a six degree of freedom, six joint, mechanical arm, configured with a mounting bracket designed to interface to a surgical/interventional table rail… The frame is also configured, in a sealed system, to allow two-way fluid communication between the ultrasound medium container and an ultrasound medium source (e.g. reservoir or fluidics management system), including, but not limited for filling and draining, as well as air venting for bubble management.” [0092]; “Enclosed iterations of the reservoir or medium container may comprise various features for sealing, in some embodiments sealing to a proximal/top portion or structure of a reservoir/container, or in other cases where sealing may comprise embodiments that seal to the transducer, or a feature on the transducer housings. Further, some embodiments may comprise the dynamic ability to control the volume of fluid within these designs, to minimize the potential for air bubbles or turbulence in said fluid. As such, integrated features allowing fluid communication, and control of, may be provided (ability to provide/remove fluid on demand), including the ability to monitor and control various fluid parameters… the overall system, and as part, the Coupling sub-system, may comprise a fluid conditioning system, which may contain various electromechanical devices, systems, power, sensing, computing and control systems, etc.” [0179].
Cannata does not explicitly teach the coupling assembly further including one or more vents.
Sihalla in the field of water sensing based systems teaches: “FIG. 2 illustrates a sensing device 201, circuit board 211, probes 205, 207 and 209 and connecting electrical cable 213. The device 201 is shown deployed below water level 203… A sample or sampling chamber 222 is shown connected to the lower portion of the sensing device 201 and placed so as to enclose the probes 205, 207 and 209 of the device 201 within the sampling chamber 222. The sampling chamber is totally water-sealed from the surrounding water and from the water sensing device 201 and the lower sections of the module 221, except for a water inlet 247 for allowing water to flow into the chamber 222, and a water outlet 248 for allowing water to be evacuated from the chamber 222 at the proper times as is hereinafter explained in greater detail. The sampling chamber 222 also has an air vent 252 which is allowed to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222. A second or component section 229 of the sampling module 221 contains a valve device 233, a pump 235 and a circuit board 231. The second section is also water sealed from the surrounding water. A third section 239 of the sampling module 221 is open to surrounding water at the bottom and through holes 242. The third section 239 acts as an interface to the surrounding water to selectively allow water to enter the sampling module through the filter material 241.” [0020-0021].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the coupling assembly of Cannata to include one or more vents as taught in Sihalla allowing “…to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222.” (Sihalla, [0021]), for the intended purpose of displacing air bubbles from a distal surface of the therapy transducer array and the coupling assembly when the treatment head is submerged in a fluid.
Regarding Claim 12, the combination of Cannata and Sihalla teach the claim limitations as noted above.
With regards to limitation: wherein the one or more vents are configured to direct the air bubbles towards one or more radial openings along a radial surface of the coupling assembly, Cannata further teaches: “The patient coupling system can comprise a six degree of freedom, six joint, mechanical arm, configured with a mounting bracket designed to interface to a surgical/interventional table rail… The frame is also configured, in a sealed system, to allow two-way fluid communication between the ultrasound medium container and an ultrasound medium source (e.g. reservoir or fluidics management system), including, but not limited for filling and draining, as well as air venting for bubble management.” [0092]; “Enclosed iterations of the reservoir or medium container may comprise various features for sealing, in some embodiments sealing to a proximal/top portion or structure of a reservoir/container, or in other cases where sealing may comprise embodiments that seal to the transducer, or a feature on the transducer housings. Further, some embodiments may comprise the dynamic ability to control the volume of fluid within these designs, to minimize the potential for air bubbles or turbulence in said fluid. As such, integrated features allowing fluid communication, and control of, may be provided (ability to provide/remove fluid on demand), including the ability to monitor and control various fluid parameters… the overall system, and as part, the Coupling sub-system, may comprise a fluid conditioning system, which may contain various electromechanical devices, systems, power, sensing, computing and control systems, etc.” [0179].
Cannata does not explicitly teach the coupling assembly further including one or more vents.
Sihalla in the field of water sensing based systems teaches: “FIG. 2 illustrates a sensing device 201, circuit board 211, probes 205, 207 and 209 and connecting electrical cable 213. The device 201 is shown deployed below water level 203… A sample or sampling chamber 222 is shown connected to the lower portion of the sensing device 201 and placed so as to enclose the probes 205, 207 and 209 of the device 201 within the sampling chamber 222. The sampling chamber is totally water-sealed from the surrounding water and from the water sensing device 201 and the lower sections of the module 221, except for a water inlet 247 for allowing water to flow into the chamber 222, and a water outlet 248 for allowing water to be evacuated from the chamber 222 at the proper times as is hereinafter explained in greater detail. The sampling chamber 222 also has an air vent 252 which is allowed to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222. A second or component section 229 of the sampling module 221 contains a valve device 233, a pump 235 and a circuit board 231. The second section is also water sealed from the surrounding water. A third section 239 of the sampling module 221 is open to surrounding water at the bottom and through holes 242. The third section 239 acts as an interface to the surrounding water to selectively allow water to enter the sampling module through the filter material 241.” [0020-0021].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the coupling assembly of Cannata to include one or more vents as taught in Sihalla allowing “…to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222.” (Sihalla, [0021]), for the intended purpose of displacing air bubbles from a distal surface of the therapy transducer array and the coupling assembly when the treatment head is submerged in a fluid.
Regarding Claim 15, the combination of Cannata and Sihalla teach the claim limitations as noted above.
Cannata further teaches: wherein the coupling assembly includes a bore configured to receive the imaging probe (“FIG. 1A generally illustrates histotripsy system 100…comprising a therapy transducer 102, an imaging system 104…The system can further include an ultrasound coupling interface and a source of coupling medium…” [0094]; “FIG. 1B is a bottom view of the therapy transducer 102 and the imaging system 104. As shown, the imaging system can be positioned in the center of the therapy transducer.” [0095]. See reproduced Fig. 1A above and Fig. 1B).
Regarding Claim 16, the combination of Cannata and Sihalla teach the claim limitations as noted above.
Cannata further teaches: wherein the coupling assembly comprises two halves which collectively form the bore (“FIG. 1A generally illustrates histotripsy system 100…comprising a therapy transducer 102, an imaging system 104…The system can further include an ultrasound coupling interface and a source of coupling medium…” [0094]; “FIG. 1B is a bottom view of the therapy transducer 102 and the imaging system 104. As shown, the imaging system can be positioned in the center of the therapy transducer.” [0095]; “The patient coupling system can comprise a six degree of freedom, six joint, mechanical arm, configured with a mounting bracket designed to interface to a surgical/interventional table rail… The frame is also configured, in a sealed system, to allow two-way fluid communication between the ultrasound medium container and an ultrasound medium source (e.g. reservoir or fluidics management system), including, but not limited for filling and draining, as well as air venting for bubble management.” [0092]; “Enclosed iterations of the reservoir or medium container may comprise various features for sealing, in some embodiments sealing to a proximal/top portion or structure of a reservoir/container, or in other cases where sealing may comprise embodiments that seal to the transducer, or a feature on the transducer housings. Further, some embodiments may comprise the dynamic ability to control the volume of fluid within these designs, to minimize the potential for air bubbles or turbulence in said fluid. As such, integrated features allowing fluid communication, and control of, may be provided (ability to provide/remove fluid on demand), including the ability to monitor and control various fluid parameters… the overall system, and as part, the Coupling sub-system, may comprise a fluid conditioning system, which may contain various electromechanical devices, systems, power, sensing, computing and control systems, etc.” [0179]. See reproduced Fig. 1A above and Fig. 1B).
Regarding Claim 17, the combination of Cannata and Sihalla teach the claim limitations as noted above.
Cannata further teaches: wherein the coupling assembly includes a distal surface that is concave (“FIG. 1A generally illustrates histotripsy system 100…comprising a therapy transducer 102, an imaging system 104…The system can further include an ultrasound coupling interface and a source of coupling medium…” [0094]; “FIG. 1B is a bottom view of the therapy transducer 102 and the imaging system 104. As shown, the imaging system can be positioned in the center of the therapy transducer.” [0095]; “The patient coupling system can comprise a six degree of freedom, six joint, mechanical arm, configured with a mounting bracket designed to interface to a surgical/interventional table rail… The frame is also configured, in a sealed system, to allow two-way fluid communication between the ultrasound medium container and an ultrasound medium source (e.g. reservoir or fluidics management system), including, but not limited for filling and draining, as well as air venting for bubble management.” [0092]; “Enclosed iterations of the reservoir or medium container may comprise various features for sealing, in some embodiments sealing to a proximal/top portion or structure of a reservoir/container, or in other cases where sealing may comprise embodiments that seal to the transducer, or a feature on the transducer housings. Further, some embodiments may comprise the dynamic ability to control the volume of fluid within these designs, to minimize the potential for air bubbles or turbulence in said fluid. As such, integrated features allowing fluid communication, and control of, may be provided (ability to provide/remove fluid on demand), including the ability to monitor and control various fluid parameters… the overall system, and as part, the Coupling sub-system, may comprise a fluid conditioning system, which may contain various electromechanical devices, systems, power, sensing, computing and control systems, etc.” [0179]. See reproduced Fig. 1A above and Fig. 1B).
Regarding Claim 19, the combination of Cannata and Sihalla teach the claim limitations as noted above.
With regards to limitation: wherein the coupling assembly includes a cavity positioned proximally from the one or more vents, Cannata further teaches: “The patient coupling system can comprise a six degree of freedom, six joint, mechanical arm, configured with a mounting bracket designed to interface to a surgical/interventional table rail… The frame is also configured, in a sealed system, to allow two-way fluid communication between the ultrasound medium container and an ultrasound medium source (e.g. reservoir or fluidics management system), including, but not limited for filling and draining, as well as air venting for bubble management.” [0092]; “Enclosed iterations of the reservoir or medium container may comprise various features for sealing, in some embodiments sealing to a proximal/top portion or structure of a reservoir/container, or in other cases where sealing may comprise embodiments that seal to the transducer, or a feature on the transducer housings. Further, some embodiments may comprise the dynamic ability to control the volume of fluid within these designs, to minimize the potential for air bubbles or turbulence in said fluid. As such, integrated features allowing fluid communication, and control of, may be provided (ability to provide/remove fluid on demand), including the ability to monitor and control various fluid parameters… the overall system, and as part, the Coupling sub-system, may comprise a fluid conditioning system, which may contain various electromechanical devices, systems, power, sensing, computing and control systems, etc.” [0179].
Cannata does not explicitly teach the coupling assembly further including one or more vents.
Sihalla in the field of water sensing based systems teaches: “FIG. 2 illustrates a sensing device 201, circuit board 211, probes 205, 207 and 209 and connecting electrical cable 213. The device 201 is shown deployed below water level 203… A sample or sampling chamber 222 is shown connected to the lower portion of the sensing device 201 and placed so as to enclose the probes 205, 207 and 209 of the device 201 within the sampling chamber 222. The sampling chamber is totally water-sealed from the surrounding water and from the water sensing device 201 and the lower sections of the module 221, except for a water inlet 247 for allowing water to flow into the chamber 222, and a water outlet 248 for allowing water to be evacuated from the chamber 222 at the proper times as is hereinafter explained in greater detail. The sampling chamber 222 also has an air vent 252 which is allowed to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222. A second or component section 229 of the sampling module 221 contains a valve device 233, a pump 235 and a circuit board 231. The second section is also water sealed from the surrounding water. A third section 239 of the sampling module 221 is open to surrounding water at the bottom and through holes 242. The third section 239 acts as an interface to the surrounding water to selectively allow water to enter the sampling module through the filter material 241.” [0020-0021].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the coupling assembly of Cannata to include one or more vents as taught in Sihalla allowing “…to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222.” (Sihalla, [0021]), for the intended purpose of displacing air bubbles from a distal surface of the therapy transducer array and the coupling assembly when the treatment head is submerged in a fluid.
Regarding Claim 20, the combination of Cannata and Sihalla teach the claim limitations as noted above.
With regards to limitation: wherein the coupling assembly is configured to direct air bubbles from the one or more vents into the cavity, Cannata further teaches: “The patient coupling system can comprise a six degree of freedom, six joint, mechanical arm, configured with a mounting bracket designed to interface to a surgical/interventional table rail… The frame is also configured, in a sealed system, to allow two-way fluid communication between the ultrasound medium container and an ultrasound medium source (e.g. reservoir or fluidics management system), including, but not limited for filling and draining, as well as air venting for bubble management.” [0092]; “Enclosed iterations of the reservoir or medium container may comprise various features for sealing, in some embodiments sealing to a proximal/top portion or structure of a reservoir/container, or in other cases where sealing may comprise embodiments that seal to the transducer, or a feature on the transducer housings. Further, some embodiments may comprise the dynamic ability to control the volume of fluid within these designs, to minimize the potential for air bubbles or turbulence in said fluid. As such, integrated features allowing fluid communication, and control of, may be provided (ability to provide/remove fluid on demand), including the ability to monitor and control various fluid parameters… the overall system, and as part, the Coupling sub-system, may comprise a fluid conditioning system, which may contain various electromechanical devices, systems, power, sensing, computing and control systems, etc.” [0179].
Cannata does not explicitly teach the coupling assembly further including one or more vents.
Sihalla in the field of water sensing based systems teaches: “FIG. 2 illustrates a sensing device 201, circuit board 211, probes 205, 207 and 209 and connecting electrical cable 213. The device 201 is shown deployed below water level 203… A sample or sampling chamber 222 is shown connected to the lower portion of the sensing device 201 and placed so as to enclose the probes 205, 207 and 209 of the device 201 within the sampling chamber 222. The sampling chamber is totally water-sealed from the surrounding water and from the water sensing device 201 and the lower sections of the module 221, except for a water inlet 247 for allowing water to flow into the chamber 222, and a water outlet 248 for allowing water to be evacuated from the chamber 222 at the proper times as is hereinafter explained in greater detail. The sampling chamber 222 also has an air vent 252 which is allowed to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222. A second or component section 229 of the sampling module 221 contains a valve device 233, a pump 235 and a circuit board 231. The second section is also water sealed from the surrounding water. A third section 239 of the sampling module 221 is open to surrounding water at the bottom and through holes 242. The third section 239 acts as an interface to the surrounding water to selectively allow water to enter the sampling module through the filter material 241.” [0020-0021].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the coupling assembly of Cannata to include one or more vents as taught in Sihalla allowing “…to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222.” (Sihalla, [0021]), for the intended purpose of displacing air bubbles from a distal surface of the therapy transducer array and the coupling assembly when the treatment head is submerged in a fluid.
Regarding Claim 21, the combination of Cannata and Sihalla teach the claim limitations as noted above.
Cannata further teaches: wherein the coupling assembly is configured for axial translation with respect to the therapy transducer array (“The patient coupling system can comprise a six degree of freedom, six joint, mechanical arm, configured with a mounting bracket designed to interface to a surgical/interventional table rail… The frame is also configured, in a sealed system, to allow two-way fluid communication between the ultrasound medium container and an ultrasound medium source (e.g. reservoir or fluidics management system), including, but not limited for filling and draining, as well as air venting for bubble management.” [0092]; “…the imaging solution may be able to move or adjust its position, including modifying angle, extension (e.g., distance from therapy transducer or patient), rotation (e.g., imaging plane in example of an ultrasound probe) and/or other parameters, including moving/adjusting dynamically while actively imaging. The imaging component or probe may be encoded so its orientation and position relative to another aspect of the system, such as the therapy transducer, and/or robotically-enabled positioning component may be determined.” [0144]; “Enclosed iterations of the reservoir or medium container may comprise various features for sealing, in some embodiments sealing to a proximal/top portion or structure of a reservoir/container, or in other cases where sealing may comprise embodiments that seal to the transducer, or a feature on the transducer housings. Further, some embodiments may comprise the dynamic ability to control the volume of fluid within these designs, to minimize the potential for air bubbles or turbulence in said fluid. As such, integrated features allowing fluid communication, and control of, may be provided (ability to provide/remove fluid on demand), including the ability to monitor and control various fluid parameters… the overall system, and as part, the Coupling sub-system, may comprise a fluid conditioning system, which may contain various electromechanical devices, systems, power, sensing, computing and control systems, etc.” [0179]).
Regarding Claim 22, the combination of Cannata and Sihalla teach the claim limitations as noted above.
With regards to limitation: wherein a distal surface of the coupling assembly is beveled or sloped inwards towards the one or more vents, Cannata further teaches: “The patient coupling system can comprise a six degree of freedom, six joint, mechanical arm, configured with a mounting bracket designed to interface to a surgical/interventional table rail… The frame is also configured, in a sealed system, to allow two-way fluid communication between the ultrasound medium container and an ultrasound medium source (e.g. reservoir or fluidics management system), including, but not limited for filling and draining, as well as air venting for bubble management.” [0092]; “Enclosed iterations of the reservoir or medium container may comprise various features for sealing, in some embodiments sealing to a proximal/top portion or structure of a reservoir/container, or in other cases where sealing may comprise embodiments that seal to the transducer, or a feature on the transducer housings. Further, some embodiments may comprise the dynamic ability to control the volume of fluid within these designs, to minimize the potential for air bubbles or turbulence in said fluid. As such, integrated features allowing fluid communication, and control of, may be provided (ability to provide/remove fluid on demand), including the ability to monitor and control various fluid parameters… the overall system, and as part, the Coupling sub-system, may comprise a fluid conditioning system, which may contain various electromechanical devices, systems, power, sensing, computing and control systems, etc.” [0179].
Cannata does not explicitly teach the coupling assembly further including one or more vents.
Sihalla in the field of water sensing based systems teaches: “FIG. 2 illustrates a sensing device 201, circuit board 211, probes 205, 207 and 209 and connecting electrical cable 213. The device 201 is shown deployed below water level 203… A sample or sampling chamber 222 is shown connected to the lower portion of the sensing device 201 and placed so as to enclose the probes 205, 207 and 209 of the device 201 within the sampling chamber 222. The sampling chamber is totally water-sealed from the surrounding water and from the water sensing device 201 and the lower sections of the module 221, except for a water inlet 247 for allowing water to flow into the chamber 222, and a water outlet 248 for allowing water to be evacuated from the chamber 222 at the proper times as is hereinafter explained in greater detail. The sampling chamber 222 also has an air vent 252 which is allowed to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222. A second or component section 229 of the sampling module 221 contains a valve device 233, a pump 235 and a circuit board 231. The second section is also water sealed from the surrounding water. A third section 239 of the sampling module 221 is open to surrounding water at the bottom and through holes 242. The third section 239 acts as an interface to the surrounding water to selectively allow water to enter the sampling module through the filter material 241.” [0020-0021].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the coupling assembly of Cannata to include one or more vents as taught in Sihalla allowing “…to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222.” (Sihalla, [0021]), for the intended purpose of displacing air bubbles from a distal surface of the therapy transducer array and the coupling assembly when the treatment head is submerged in a fluid.
Regarding Claim 23, the combination of Cannata and Sihalla teach the claim limitations as noted above.
With regards to limitation: wherein a distal surface of the venting assembly is beveled or sloped inwards towards the one or more vents, Cannata further teaches: “The patient coupling system can comprise a six degree of freedom, six joint, mechanical arm, configured with a mounting bracket designed to interface to a surgical/interventional table rail… The frame is also configured, in a sealed system, to allow two-way fluid communication between the ultrasound medium container and an ultrasound medium source (e.g. reservoir or fluidics management system), including, but not limited for filling and draining, as well as air venting for bubble management.” [0092]; “Enclosed iterations of the reservoir or medium container may comprise various features for sealing, in some embodiments sealing to a proximal/top portion or structure of a reservoir/container, or in other cases where sealing may comprise embodiments that seal to the transducer, or a feature on the transducer housings. Further, some embodiments may comprise the dynamic ability to control the volume of fluid within these designs, to minimize the potential for air bubbles or turbulence in said fluid. As such, integrated features allowing fluid communication, and control of, may be provided (ability to provide/remove fluid on demand), including the ability to monitor and control various fluid parameters… the overall system, and as part, the Coupling sub-system, may comprise a fluid conditioning system, which may contain various electromechanical devices, systems, power, sensing, computing and control systems, etc.” [0179].
Cannata does not explicitly teach the coupling assembly further including one or more vents.
Sihalla in the field of water sensing based systems teaches: “FIG. 2 illustrates a sensing device 201, circuit board 211, probes 205, 207 and 209 and connecting electrical cable 213. The device 201 is shown deployed below water level 203… A sample or sampling chamber 222 is shown connected to the lower portion of the sensing device 201 and placed so as to enclose the probes 205, 207 and 209 of the device 201 within the sampling chamber 222. The sampling chamber is totally water-sealed from the surrounding water and from the water sensing device 201 and the lower sections of the module 221, except for a water inlet 247 for allowing water to flow into the chamber 222, and a water outlet 248 for allowing water to be evacuated from the chamber 222 at the proper times as is hereinafter explained in greater detail. The sampling chamber 222 also has an air vent 252 which is allowed to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222. A second or component section 229 of the sampling module 221 contains a valve device 233, a pump 235 and a circuit board 231. The second section is also water sealed from the surrounding water. A third section 239 of the sampling module 221 is open to surrounding water at the bottom and through holes 242. The third section 239 acts as an interface to the surrounding water to selectively allow water to enter the sampling module through the filter material 241.” [0020-0021].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the coupling assembly of Cannata to include one or more vents as taught in Sihalla allowing “…to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222.” (Sihalla, [0021]), for the intended purpose of displacing air bubbles from a distal surface of the therapy transducer array and the coupling assembly when the treatment head is submerged in a fluid.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Cannata and Sihalla in view of Jahnke et. al. (U.S. 9061131, June 23, 2015)(hereinafter, “Jahnke”).
Regarding Claim 5, the combination of Cannata and Sihalla teach the claim limitations as noted above.
Sihalla in the field of water sensing based systems teaches: “FIG. 2 illustrates a sensing device 201, circuit board 211, probes 205, 207 and 209 and connecting electrical cable 213. The device 201 is shown deployed below water level 203… A sample or sampling chamber 222 is shown connected to the lower portion of the sensing device 201 and placed so as to enclose the probes 205, 207 and 209 of the device 201 within the sampling chamber 222. The sampling chamber is totally water-sealed from the surrounding water and from the water sensing device 201 and the lower sections of the module 221, except for a water inlet 247 for allowing water to flow into the chamber 222, and a water outlet 248 for allowing water to be evacuated from the chamber 222 at the proper times as is hereinafter explained in greater detail. The sampling chamber 222 also has an air vent 252 which is allowed to vent to outside air through air vent tube 253. Outside air moves through the air vent into the chamber when water is being pumped out of the chamber 222, and air is forced through the air vent 252 to outside air supply as water is allowed to fill the sampling chamber 222. A second or component section 229 of the sampling module 221 contains a valve device 233, a pump 235 and a circuit board 231. The second section is also water sealed from the surrounding water. A third section 239 of the sampling module 221 is open to surrounding water at the bottom and through holes 242. The third section 239 acts as an interface to the surrounding water to selectively allow water to enter the sampling module through the filter material 241.” [0020-0021].
The combination does not teach: three and four vents.
Jahnke in the field of medical imaging therapy devices teaches: “Vents 856 can be provided at the top or at other locations in the ultrasound therapy transducer to facilitate conformance of the bladder to the concave surface. In some embodiments, the vents can include a one way valve that allows air to escape and not return from the space between the bladder and concave surface. In this manner, the one way valve vent can create a vacuum in the space between the bladder and the concave surface. Similarly, a vent 856 in the skin adapter at the patient skin surface 858 can be provided to facilitate conformance of the bladder to the curves on the skin surface. This vent may also include a one way valve to facilitate creation of a vacuum between the bladder and patient skin surface.”; see Figs. 7-8. Column 9, lines 42-54).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to include three and four vents as taught in Jahnke for the intended purpose of displacing air bubbles from a distal surface of the therapy transducer array and to facilitate creation of a vacuum between a container structure and the patient skin surface (Jahnke, Column 9, lines 52-54).
Regarding Claim 6, the combination of Cannata and Sihalla teach the claim limitations as noted above.
The combination of Cannata and Sihalla does not teach: further comprising at least four vents, wherein the four vents are disposed approximately 90 degrees apart around a bore in the coupling assembly configured to receive the imaging probe.
Jahnke in the field of medical imaging therapy devices teaches: “Vents 856 can be provided at the top or at other locations in the ultrasound therapy transducer to facilitate conformance of the bladder to the concave surface. In some embodiments, the vents can include a one way valve that allows air to escape and not return from the space between the bladder and concave surface. In this manner, the one way valve vent can create a vacuum in the space between the bladder and the concave surface. Similarly, a vent 856 in the skin adapter at the patient skin surface 858 can be provided to facilitate conformance of the bladder to the curves on the skin surface. This vent may also include a one way valve to facilitate creation of a vacuum between the bladder and patient skin surface.”; see Figs. 7-8. Column 9, lines 42-54).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to include at least four vents, wherein the four vents are disposed approximately 90 degrees apart as taught in Jahnke for the intended purpose of displacing air bubbles from a distal surface of the therapy transducer array and to facilitate creation of a vacuum between a container structure and the patient skin surface (Jahnke, Column 9, lines 52-54).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Cannata and Sihalla as applied to claim 1 above, and further in view of Janovjak et. al. (U.S. 20190062761, February 28, 2019)(hereinafter, “Janovjak”).
Regarding Claim 24, the combination of Cannata and Sihalla teach the claim limitations as noted above.
The combination of references does not teach: wherein the coupling assembly comprises a zero-swell material.
Janovjak in the field of ultrasound-based systems teaches: “A thin walled (8 mm wall thickness) aluminum chamber was constructed to fit on top of the transducer element. The chamber was filled with water as the heating material and the temperature increase in response to stimulation was measured using a digital thermometer.” [0267].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the coupling assembly in the combination of references to comprise a zero-swell material as taught in Janovjak for high thermal conductivity and low density for efficient and uniform degassing and cleaning.
Regarding Claim 25, the combination of Cannata, Sihalla and Janovjak teach the claim limitations as noted above.
The combination of Cannata, Sihalla do not teach wherein the zero-swell material comprises aluminum.
Janovjak in the field of ultrasound-based systems teaches: “A thin walled (8 mm wall thickness) aluminum chamber was constructed to fit on top of the transducer element. The chamber was filled with water as the heating material and the temperature increase in response to stimulation was measured using a digital thermometer.” [0267].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the zero-swell material in the combination of refences to comprise aluminum as taught in Janovjak for high thermal conductivity and low density for efficient and uniform degassing and cleaning.
Response to Arguments
Applicant’s arguments with respect to previous 35 U.S.C. 102 and 103 rejections of claims 1-12, 15-17 and 19-25 have been considered but are moot because the new ground of rejection does not rely on reference Konofagou applied in the prior rejection of record for any teaching or matter specifically challenged in the arguments.
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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/AMAL ALY FARAG/Primary Examiner, Art Unit 3798
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