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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/13/2025 has been entered.
Response to Amendment
This action is in response to the RCE filed on 11/13/2025. The amendments and remarks filed on 11/13/2025. have been entered. Accordingly Claims 1, 7-13 and 19-30 are pending. Claims 28-30 are new. The previous drawing and specification objections and rejections of claims 1, 7-13 and 19-27 have been withdrawn in light of Applicant’s amendments and remarks in the claim set filed 11/13/2025.
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, 7-9, 19-21, 23, 25 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Crowley (U.S. 5840031, November 24, 19998)(hereinafter, “Crowley”) in view of Peszynski et. al. (U.S. 6592520, July 15, 2003)(hereinafter, “Peszynski”).
Regrading Claim 1, Crowley teaches: A nasal trans-esophageal echocardiography system (Figs. 1 and 33) comprising:
a trans-esophageal device comprising a sheath defining a first lumen therein, said sheath having a width sufficiently narrow to fit through a nasal passage of a subject, the sheath having a proximal end and a distal end (Fig. 19, element 12d, sheath, “FIGS. 19-19c show a catheter sheath 12d on which is mounted a balloon 55 very near the tip of catheter sheath 12d. The balloon is adapted to be pressurized with liquid, such as saline or water, or a gas, such as air, through the same lumen that holds the ultrasound imaging device, via an inflation opening in the wall of the catheter sheath.”, column 16. see reproduced Fig. 19 below ; “According to this imaging mode, the heart 352 is imaged through the esophagus 354…”, column 22);
a balloon attached to the distal end of the sheath (Fig. 19, element 55, balloon, “FIGS. 19-19c show a catheter sheath 12d on which is mounted a balloon 55 very near the tip of catheter sheath 12d. The balloon is adapted to be pressurized with liquid, such as saline or water, or a gas, such as air, through the same lumen that holds the ultrasound imaging device, via an inflation opening in the wall of the catheter sheath.”, column 16. see reproduced Fig. 19 below);
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a side port in the sheath, the side port being located near said proximal end of the sheath, the side port being configured for injection of a fluid through the first lumen into the balloon located at the distal end of sheath (“FIGS. 19-19c show a catheter sheath 12d on which is mounted a balloon 55 very near the tip of catheter sheath 12d. The balloon is adapted to be pressurized with liquid, such as saline or water, or a gas, such as air, through the same lumen that holds the ultrasound imaging device, via an inflation opening in the wall of the catheter sheath.”, column 16.; “Fluid communication between the balloon and the catheter may be provided through a port.”, column 18. see reproduced Fig. 19 above and Fig. 22);
an ultrasound probe having a width sufficiently narrow to extend through said first lumen defined by said sheath from the proximal end of the sheath to the distal end of the sheath (“A rotating ultrasound transducer having a coil form drive shaft, as discussed herein above, is positioned on the central axis of the catheter sheath 139 at a position corresponding to the inflatable balloon 140.”, column 18); and
a workstation configured to communicate with said ultrasound probe to receive ultrasound signals from said ultrasound probe and to form ultrasound images based on said ultrasound signals (“…as discussed for example with respect to FIGS. 8-8a, to the acoustic imaging control system as discussed for example with respect to FIG. 1, for transmitting rotary power and control signals to the acoustic imaging transducer held within the balloon catheter sheath 139 near balloon 140 and for receiving acoustical image signals from the transducer.”, column 18).
Crowley does not teach: a sheath handle coupled to a proximal end of the sheath, the sheath handle configured to maneuver a tip of the sheath at the distal end of the sheath.
Peszynski in the field of ultrasound catheter-based imaging systems teaches: “The steerable guide sheath is connectable to a sheath handle, which is connectable to the catheter handle. “ (column 5, lines 38-40); “Also referring to FIG. 2, imaging catheter 12 includes an imaging core 40 insertable into a steerable guide sheath 60. Steerable guide sheath 60 includes a distal sheath part 30A having a rigid sheath region 32A and an articulation region 34A. Steerable guide sheath 60 is at its proximal end connected to a guide sheath handle 14A.” (column 8, lines 3-8).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Crowley to include a sheath handle coupled to a proximal end of the sheath for the intended purpose of maneuvering a tip of the sheath at the distal end of the sheath, improving security and protection of the system components.
Regarding Claim 7, the combination of Crowley and Peszynski teach the claim limitations as noted above.
Crowley further teaches: wherein said sheath further defines a second lumen therein, the second lumen being in fluid communication with the first lumen, and wherein said side port is configured for injection of said fluid through said second lumen defined by said sheath into said first lumen and said balloon (“FIG. 16 shows sheath 12f on which are mounted electrodes 300 for electrophysiology or ablation. Sheath 12f has a two lumen construction. The large lumen contains the transducer and drive shaft while the small lumen contains a wire 94.”, column 13;“FIGS. 19-19c show a catheter sheath 12d on which is mounted a balloon 55 very near the tip of catheter sheath 12d. The balloon is adapted to be pressurized with liquid, such as saline or water, or a gas, such as air, through the same lumen that holds the ultrasound imaging device, via an inflation opening in the wall of the catheter sheath.”, column 16.; “Fluid communication between the balloon and the catheter may be provided through a port.”, column 18. see reproduced Fig. 19 above and Fig. 22).
Regarding Claim 8, the combination of Crowley and Peszynski teach the claim limitations as noted above.
Crowley further teaches: further comprising a sheath control assembly attached to the proximal end of said sheath, wherein said sheath control assembly provides adjustable deflections of the distal end of said sheath with at least one degree of freedom (“FIG. 16 shows sheath 12f on which are mounted electrodes 300 for electrophysiology or ablation. Sheath 12f has a two lumen construction. The large lumen contains the transducer and drive shaft while the small lumen contains a wire 94. As shown, wire 94 is a deflecting or steering wire attached near the distal end, and is free to slide through its lumen under tension applied to ring 96 to cause the catheter to bend when pulled taut, thus providing a measure of control of the orientation of the distal end of the acoustic catheter while negotiating the passages of the body or the like.”, column 13;“…as discussed for example with respect to FIGS. 8-8a, to the acoustic imaging control system as discussed for example with respect to FIG. 1, for transmitting rotary power and control signals to the acoustic imaging transducer held within the balloon catheter sheath 139 near balloon 140 and for receiving acoustical image signals from the transducer.”, column 18. see reproduced Fig. 19 above and Fig. 22).
Regarding Claim 9, the combination of Crowley and Peszynski teach the claim limitations as noted above.
Crowley further teaches: wherein said balloon has one of a spherical, elongated, hexagonal of asymmetrical shape (See Figs 19-20).
Regarding Claims 11 and 12, the combination of Crowley and Peszynski teach the claim limitations as noted above.
Crowley further teaches: further comprising a trocar having a width sufficiently narrow to be inserted into said first lumen defined by said sheath, said trocar being more rigid than said sheath to provide sturdiness and stability to said sheath and to said balloon while deflated during insertion of said sheath into said nasal passage of said subject; wherein said trocar defines a lumen therein such that fluid can be injected proximally to exit at a distal end of said trocar and displace gas from inside at least one of said sheath or said balloon (“FIGS. 19-19c show a catheter sheath 12d on which is mounted a balloon 55 very near the tip of catheter sheath 12d. The balloon is adapted to be pressurized with liquid, such as saline or water, or a gas, such as air, through the same lumen that holds the ultrasound imaging device, via an inflation opening in the wall of the catheter sheath.”, column 16; “…the balloon contracts in a folded manner which leaves air passages through the interior of the balloon. A hypodermic syringe fitted with a small gauge needle [trocar] and filled with a fluid such as water or saline is then inserted through a septum seal at the distal tip of the catheter sheath. Fluid is introduced until surplus exits the side arm, at which point the valve is closed, reducing the chances that air will re-enter the catheter. Alternately, the fluid may be introduced via the side arm when an air venting needle is inserted into the distal septum.”, column 19).
Regarding Claim 13, Crowley teaches: A nasal trans-esophageal device (Figs. 1 and 33) comprising:
a sheath defining a first lumen therein, said sheath having a width and said first lumen having a width to be able to receive an intracardiac echocardiography probe to be threaded through said first lumen, the sheath having a proximal end and a distal end (Fig. 19, element 12d, sheath, “FIGS. 19-19c show a catheter sheath 12d on which is mounted a balloon 55 very near the tip of catheter sheath 12d. The balloon is adapted to be pressurized with liquid, such as saline or water, or a gas, such as air, through the same lumen that holds the ultrasound imaging device, via an inflation opening in the wall of the catheter sheath.”, column 16. see reproduced Fig. 19 below ; “According to this imaging mode, the heart 352 is imaged through the esophagus 354…”, column 22);
a balloon attached to the distal end of the sheath (Fig. 19, element 55, balloon, “FIGS. 19-19c show a catheter sheath 12d on which is mounted a balloon 55 very near the tip of catheter sheath 12d. The balloon is adapted to be pressurized with liquid, such as saline or water, or a gas, such as air, through the same lumen that holds the ultrasound imaging device, via an inflation opening in the wall of the catheter sheath.”, column 16. see reproduced Fig. 19 above);
and a side port in the sheath, the side port being located near said proximal end of the sheath, the side port being configured for injection of a fluid through the first lumen into the balloon located at the distal end of sheath (“FIGS. 19-19c show a catheter sheath 12d on which is mounted a balloon 55 very near the tip of catheter sheath 12d. The balloon is adapted to be pressurized with liquid, such as saline or water, or a gas, such as air, through the same lumen that holds the ultrasound imaging device, via an inflation opening in the wall of the catheter sheath.”, column 16.; “Fluid communication between the balloon and the catheter may be provided through a port.”, column 18. see reproduced Fig. 19 above and Fig. 22).
Crowley does not teach: a sheath handle coupled to a proximal end of the sheath, the sheath handle configured to maneuver a tip of the sheath at the distal end of the sheath.
Peszynski in the field of ultrasound catheter-based imaging systems teaches: “The steerable guide sheath is connectable to a sheath handle, which is connectable to the catheter handle. “ (column 5, lines 38-40); “Also referring to FIG. 2, imaging catheter 12 includes an imaging core 40 insertable into a steerable guide sheath 60. Steerable guide sheath 60 includes a distal sheath part 30A having a rigid sheath region 32A and an articulation region 34A. Steerable guide sheath 60 is at its proximal end connected to a guide sheath handle 14A.” (column 8, lines 3-8).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Crowley to include a sheath handle coupled to a proximal end of the sheath for the intended purpose of maneuvering a tip of the sheath at the distal end of the sheath, improving security and protection of the system components.
Regarding Claim 19, the combination of Crowley and Peszynski teach the claim limitations as noted above.
Claim 19 further recites limitations: wherein said sheath further defines a second lumen therein, the second lumen being in fluid communication with the first lumen, and wherein said side port is configured for injection of said fluid through said second lumen defined by said sheath into said first lumen and into said balloon. These limitations are present in claim 7 and is therefore, rejected under the same rationale.
Regarding Claim 20, the combination of Crowley and Peszynski teach the claim limitations as noted above.
Claim 20 further recites limitations: further comprising a sheath control assembly attached to the proximal end of said sheath, wherein said sheath control assembly provides adjustable deflections of the distal end of said sheath with at least one degree of freedom. These limitations are present in claim 8 and is therefore, rejected under the same rationale.
Regarding Claim 21, the combination of Crowley and Peszynski teach the claim limitations as noted above.
Claim 21 further recites limitations: wherein said balloon has one of a spherical, elongated, hexagonal of asymmetrical shape. These limitations are present in claim 9 and is therefore, rejected under the same rationale.
Regarding Claim 23, the combination of Crowley and Peszynski teach the claim limitations as noted above.
Crowley further teaches: wherein said balloon is semipermeable (“FIGS. 19-19c show a catheter sheath 12d on which is mounted a balloon 55 very near the tip of catheter sheath 12d. The balloon is adapted to be pressurized with liquid, such as saline or water, or a gas, such as air, through the same lumen that holds the ultrasound imaging device, via an inflation opening in the wall of the catheter sheath.”, column 16; “…the balloon contracts in a folded manner which leaves air passages through the interior of the balloon. A hypodermic syringe fitted with a small gauge needle and filled with a fluid such as water or saline is then inserted through a septum seal at the distal tip of the catheter sheath. Fluid is introduced until surplus exits the side arm, at which point the valve is closed, reducing the chances that air will re-enter the catheter. Alternately, the fluid may be introduced via the side arm when an air venting needle is inserted into the distal septum.”, column 19).
Regarding Claim 25, the combination of Crowley and Peszynski teach the claim limitations as noted above.
Crowley further teaches: further comprising a hollow tip at a distal end of the balloon, wherein the ultrasound probe has a tip configured to extend into the hollow tip to optimally position the ultrasound probe within the balloon (“FIGS. 19-19c show a catheter sheath 12d on which is mounted a balloon 55 very near the tip of catheter sheath 12d. The balloon is adapted to be pressurized with liquid, such as saline or water, or a gas, such as air, through the same lumen that holds the ultrasound imaging device, via an inflation opening in the wall of the catheter sheath.”, column 16; “…the balloon contracts in a folded manner which leaves air passages through the interior of the balloon. A hypodermic syringe fitted with a small gauge needle [trocar] and filled with a fluid such as water or saline is then inserted through a septum seal at the distal tip of the catheter sheath. Fluid is introduced until surplus exits the side arm, at which point the valve is closed, reducing the chances that air will re-enter the catheter. Alternately, the fluid may be introduced via the side arm when an air venting needle is inserted into the distal septum.”, column 19).
Regarding Claim 28, the combination of Crowley and Peszynski teach the claim limitations as noted above.
Crowley further teaches: further comprising a probe handle coupled to said ultrasound probe, the probe handle being configured to manipulate the ultrasound probe, wherein the probe handle is in communication with the workstation (“The longitudinal and rotational position of hollow bushing 11 relative to the housing is adjustable. Drive shaft coil assembly 18, thus attached at its proximal end to connector 16 of drive motor 20, rotates transducer 10 at speeds of about 1800 rpm. The transducer 10 is electrically connected by coaxial cable 32 extending through coil assembly 18 and via the cable through the motor to the proximal electronic components 22 which send, receive and interpret signals from the transducer.” (column 8, lines 21-29);“ Various improved transesophageal probes can vary the plane scanned through the heart through various angles and various rotational and azimuthal positions, and can therefore be used to image a very wide area of the heart through manipulation of controls on the proximal end of the transesophageal probe. During use, transesophageal probe 356 is first placed in a patient's esophagus prior to the beginning of an electrophysiology procedure, and electrophysiology or ablation catheters 358 and 359 are then placed in the heart through the venous or the arterial system.” (column 22-23, lines 66-8).
Regarding Claim 29, the combination of Crowley and Peszynski teach the claim limitations as noted above.
with regards to limitations: wherein the probe handle is moveable to lay inside the sheath handle, Crowley teaches: “The longitudinal and rotational position of hollow bushing 11 relative to the housing is adjustable. Drive shaft coil assembly 18, thus attached at its proximal end to connector 16 of drive motor 20, rotates transducer 10 at speeds of about 1800 rpm. The transducer 10 is electrically connected by coaxial cable 32 extending through coil assembly 18 and via the cable through the motor to the proximal electronic components 22 which send, receive and interpret signals from the transducer.” (column 8, lines 21-29); “FIGS. 19-19c show a catheter sheath 12d on which is mounted a balloon 55 very near the tip of catheter sheath 12d. The balloon is adapted to be pressurized with liquid, such as saline or water, or a gas, such as air, through the same lumen that holds the ultrasound imaging device, via an inflation opening in the wall of the catheter sheath.”, column 16.; “Fluid communication between the balloon and the catheter may be provided through a port.”, column 18; “ Various improved transesophageal probes can vary the plane scanned through the heart through various angles and various rotational and azimuthal positions, and can therefore be used to image a very wide area of the heart through manipulation of controls on the proximal end of the transesophageal probe. During use, transesophageal probe 356 is first placed in a patient's esophagus prior to the beginning of an electrophysiology procedure, and electrophysiology or ablation catheters 358 and 359 are then placed in the heart through the venous or the arterial system.” (column 22-23, lines 66-8.
Crowley does not teach: a sheath handle.
Peszynski in the field of ultrasound catheter-based imaging systems teaches: “The steerable guide sheath is connectable to a sheath handle, which is connectable to the catheter handle. “ (column 5, lines 38-40); “Also referring to FIG. 2, imaging catheter 12 includes an imaging core 40 insertable into a steerable guide sheath 60. Steerable guide sheath 60 includes a distal sheath part 30A having a rigid sheath region 32A and an articulation region 34A. Steerable guide sheath 60 is at its proximal end connected to a guide sheath handle 14A.” (column 8, lines 3-8).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Crowley to include a sheath handle wherein the probe handle is moveable to lay inside the sheath handle as taught in Peszynsk for improving security and protection of the system components.
Regarding Claim 30, the combination of Crowley and Peszynski teach the claim limitations as noted above.
With regards to limitations: wherein the sheath handle comprises sheath controls and the probe handle comprises probe controls, the probe controls being configured to line up with the sheath controls when the probe handle is inside the sheath handle, Crowley further teaches: “The longitudinal and rotational position of hollow bushing 11 relative to the housing is adjustable. Drive shaft coil assembly 18, thus attached at its proximal end to connector 16 of drive motor 20, rotates transducer 10 at speeds of about 1800 rpm. The transducer 10 is electrically connected by coaxial cable 32 extending through coil assembly 18 and via the cable through the motor to the proximal electronic components 22 which send, receive and interpret signals from the transducer.” (column 8, lines 21-29); “FIGS. 19-19c show a catheter sheath 12d on which is mounted a balloon 55 very near the tip of catheter sheath 12d. The balloon is adapted to be pressurized with liquid, such as saline or water, or a gas, such as air, through the same lumen that holds the ultrasound imaging device, via an inflation opening in the wall of the catheter sheath.”, column 16.; “Fluid communication between the balloon and the catheter may be provided through a port.”, column 18; “ Various improved transesophageal probes can vary the plane scanned through the heart through various angles and various rotational and azimuthal positions, and can therefore be used to image a very wide area of the heart through manipulation of controls on the proximal end of the transesophageal probe. During use, transesophageal probe 356 is first placed in a patient's esophagus prior to the beginning of an electrophysiology procedure, and electrophysiology or ablation catheters 358 and 359 are then placed in the heart through the venous or the arterial system.” (column 22-23, lines 66-8.
Crowley does not teach: a sheath handle comprising sheath controls.
Peszynski in the field of ultrasound catheter-based imaging systems teaches: “The steerable guide sheath is connectable to a sheath handle, which is connectable to the catheter handle. “ (column 5, lines 38-40); “Also referring to FIG. 2, imaging catheter 12 includes an imaging core 40 insertable into a steerable guide sheath 60. Steerable guide sheath 60 includes a distal sheath part 30A having a rigid sheath region 32A and an articulation region 34A. Steerable guide sheath 60 is at its proximal end connected to a guide sheath handle 14A.” (column 8, lines 3-8); “Guide sheath adapter 15 includes a housing 100, a V-band clamp actuator 102, a push-pull actuator 104 connected to a rack and pinion mechanism 106, and O-rings 108A, 108B and 108C. O-rings 108A, 108B and 108C seal guide sheath handle 15A to catheter handle 14…” (column 9, lines 40-44).
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 of references to include a sheath handle comprising sheath controls as taught in Peszynsk for improving maneuverability and orientation of the sheath for protection of the system components.
Claims 10 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Crowley in view of Peszynski as applied to claims 1 and 13, respectively above, and further in view of Elmont et. al. (U.S. 20180353390, December 13, 2018)(hereinafter, “Elmont”).
Regarding Claim 10, the combination of Crowley and Peszynski teach the claim limitations as noted above.
Crowley further teaches: “FIGS. 19-19c show a catheter sheath 12d on which is mounted a balloon 55 very near the tip of catheter sheath 12d. The balloon is adapted to be pressurized with liquid, such as saline or water, or a gas, such as air, through the same lumen that holds the ultrasound imaging device, via an inflation opening in the wall of the catheter sheath.”, column 16; “…the balloon contracts in a folded manner which leaves air passages through the interior of the balloon. A hypodermic syringe fitted with a small gauge needle [trocar] and filled with a fluid such as water or saline is then inserted through a septum seal at the distal tip of the catheter sheath. Fluid is introduced until surplus exits the side arm, at which point the valve is closed, reducing the chances that air will re-enter the catheter. Alternately, the fluid may be introduced via the side arm when an air venting needle is inserted into the distal septum.”, column 19.
Crowley does not explicitly teach: wherein said sheath has a semipermeable portion at the distal end thereof that is permeable to gas and not liquid.
Elmont in the field of catheter-based systems teaches: “…the sheath 220 can be configured to selectively allow passage of one or more substances into and/or out of the catheter 210… the sheath 220 comprises a permeable or semi-permeable membrane…the membrane can allow passage of one or more gases, while restricting (or otherwise minimizing) the passage of other molecules such as liquids and solids (e.g., liquid and/or solid foods, aqueous liquids, or other bodily fluids, etc.). In other words, the membrane can be described as being permeable to one or more gases, and impermeable (or substantially impermeable) to other substances (e.g., such as liquids and solids).” [0035].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sheath in the combination of references to have a semipermeable portion that is permeable to gas and not liquid as taught in Elmont to “…allow passage of one or more gases, while restricting (or otherwise minimizing) the passage of other molecules…”(Elmont, [0035]).
Regarding Claim 22, the combination of Crowley and Peszynski teach the claim limitations as noted above.
Crowley further teaches: “FIGS. 19-19c show a catheter sheath 12d on which is mounted a balloon 55 very near the tip of catheter sheath 12d. The balloon is adapted to be pressurized with liquid, such as saline or water, or a gas, such as air, through the same lumen that holds the ultrasound imaging device, via an inflation opening in the wall of the catheter sheath.”, column 16; “…the balloon contracts in a folded manner which leaves air passages through the interior of the balloon. A hypodermic syringe fitted with a small gauge needle and filled with a fluid such as water or saline is then inserted through a septum seal at the distal tip of the catheter sheath. Fluid is introduced until surplus exits the side arm, at which point the valve is closed, reducing the chances that air will re-enter the catheter. Alternately, the fluid may be introduced via the side arm when an air venting needle is inserted into the distal septum.”, column 19.
Crowley does not explicitly teach: wherein said sheath has a semipermeable portion at the distal end thereof.
Elmont in the field of catheter-based systems teaches: “the sheath 220 can be configured to selectively allow passage of one or more substances into and/or out of the catheter 210… the sheath 220 comprises a permeable or semi-permeable membrane…the membrane can allow passage of one or more gases, while restricting (or otherwise minimizing) the passage of other molecules such as liquids and solids (e.g., liquid and/or solid foods, aqueous liquids, or other bodily fluids, etc.). In other words, the membrane can be described as being permeable to one or more gases, and impermeable (or substantially impermeable) to other substances (e.g., such as liquids and solids).” [0035].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sheath in the combination of references to have a semipermeable portion as taught in Elmont to “…allow passage of one or more gases, while restricting (or otherwise minimizing) the passage of other molecules…”(Elmont, [0035]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Crowley in view of Peszynski as applied to claim 1 above, and further in view of Molnar (U.S. 20170209022, July 27, 2017)(hereinafter, “Molnar”).
Regarding Claim 24, the combination of Crowley and Peszynski teach the claim limitations as noted above.
With regards to limitations: further comprising a trumpet configured to be inserted into a nasal cavity and having a working conduit configured to receive the sheath of the nasal trans-esophageal device.
Moore teaches a trans-esophageal catheter: ““FIGS. 19-19c show a catheter sheath 12d on which is mounted a balloon 55 very near the tip of catheter sheath 12d. The balloon is adapted to be pressurized with liquid, such as saline or water, or a gas, such as air, through the same lumen that holds the ultrasound imaging device, via an inflation opening in the wall of the catheter sheath.”, column 16. see reproduced Fig. 19 below ; “According to this imaging mode, the heart 352 is imaged through the esophagus 354…”, column 22. See Figs. 19 and 22).
Crowley does not explicitly teach a trumpet.
Molnar in the field of medical devices placed into a patient such as a trachea teaches: “…a nasal trumpet with a visualization device, generally 220 in FIG. 15. The trumpet 220 comprises a tubal body 222 with a proximal end 222B and a distal end 222A. Two fasteners 224 are attached at the proximal end 222B of the tubal body 222. After placing the trumpet 220 in a patient, the proximal portion of the tubal body 222 with the fasteners 224 remains outside of the patient, and the fasteners 224 can be used to secure the trumpet 220 around the patient's head.” [0156]. See Fig. 15.
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 of references to include a trumpet as taught in Molnar for accurate and proper placement of a medical device into a patient (Molnar, [0004]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Crowley in view of Peszynski as applied to claim 25 above, and further in view of McMurtry et. al. (U.S. 20150202408, July 23, 1025)(hereinafter, “McMurtry”).
Regarding Claim 26, the combination of Crowley and Peszynski teach the claim limitations as noted above.
Crowley does not teach: wherein the hollow tip includes one or more magnets to capture the tip of the ultrasound probe.
McMurtry in the field of catheter-based systems teaches : “The sensing of the tip of the catheter is accomplished by imbedding a ring magnet 30 into the tip of the catheter…” [0047].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tip in the combination of references to include a magnet as taught in McMurtry for the intended purpose of capturing the tip of the ultrasound probe.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Crowley in view of Peszynski as applied to claim 25 above, and further in view of Kreck et. al. (U.S. 20130030411, January 31, 2013)(hereinafter, “Kreck”).
Regarding Claim 27, the combination of Crowley and Peszynski teach the claim limitations as noted above.
Crowley does not teach: further comprising a fluid coolant reservoir and an associated fluid coolant pump configured to pump coolant fluid to maintain optimal temperature of the tip pf the ultrasound probe.
Kreck in the field of catheter-based systems teaches: “A box open at the top acted as a reservoir for cooling liquid. The reservoir was filled with a 1:1 mixture of propylene glycol and water at -15.degree. C. Pumps withdrew fluid from the reservoir at 1 L/min for pump 1, and 3 L/min for pump 2 and 5 L/min for pump 3 for a total of 9 L/min through the internally placed catheters.” [0285].
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 of references to include a fluid coolant reservoir and an associated fluid coolant pump configured to pump coolant fluid as taught in Kreck for the intended purpose of maintaining optimal temperature of the tip pf the ultrasound probe.
Response to Arguments
Applicant’s arguments regarding amended claims 1 and 13 are moot in view of the new grounds of rejections.
Conclusion
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/AMAL ALY FARAG/ Primary Examiner, Art Unit 3798