DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 3/01/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Blaivas et al. (U.S. Pub. No. 20130131501) hereinafter Blaivas, in view of Grim et al. (U.S. Pub. No. 20170303889) hereinafter Grim.
Regarding claim 1, primary reference Blaivas teaches:
A sonographically-aided blood vessel penetration device (abstract), comprising:
a casing ([0066]-[0067], cartridge 90 includes needle/cannula introducer and forms a casing for the introducer; [0106]-[0109], figures 40-42 include the cartridge 90 which forms a casing around the cannula/catheter system)
a penetration assembly that defines a channel and has a central venous catheter (CVC) that is slidable between a retracted configuration and a deployed configuration ([0043], catheter placement; [0047], advancement and retraction of the cannula (analogous to catheter for CVC procedure) during procedures; [0052], advancement and retraction; [0055], advancement and retraction of cannula system; [0058], injector for introduction of catheter and retraction of needle in and out of the assembly; [0064], central catheter lines; [0083], CVC catheter procedure for introduction into a patient using the introducer device; [0094]-[0095]; [0106]-[0110], needle/cannula retraction and use of cartridge 90 for deployment as in figures 40-42; [0111], introduced catheter into the patient);
a sonograph assembly having at least one sensor pad and adjacent said outlet, said sonograph assembly being in data communication with an electronic sonograph module ([0043]-[0050], ultrasound transducer forms a sonograph assembly with a sensor pad (transducer element) located adjacent to the needle outlet and in data communication with ultrasound electronics (sonograph module); [0058], ultrasound probe; [0062]-[0065], ultrasound transceiver housing; [0068]-[0070], transducer base 16 of ultrasound transceiver housing 12 forms the sensor pad adjacent to the outlet; [0080]-[0085]; figures 15-20; [0115]);
Primary reference Blaivas fails to teach:
a casing having a rear wall and a continuous sidewall extending from a peripheral edge of said rear wall and a front wall opposite said rear wall, said rear wall, said sidewall, and said front wall, together, defining an interior area,
said casing having a bottom face that defines an outlet proximate said front wall;
a penetration assembly positioned in said interior area that defines a channel and has a central venous catheter (CVC) that is slidable between a retracted configuration positioned entirely in said channel and a deployed configuration extending through said outlet and positioned partially outside of said interior area;
a sonograph assembly having at least one sensor pad positioned on a bottom face of said casing and adjacent said outlet, said sonograph assembly being in data communication with an electronic sonograph module;
a display positioned on a top face of said casing and in data communication with said sonograph module;
an actuator assembly positioned on said casing that includes in input member proximate said top face and a linkage extending between said input member and said CVC, said linkage being slidable so as to cause said CVC to move from said retracted configuration to said deployed configuration when said input member is actuated by a
However, the analogous art of Grim of an ultrasound-guided needle introducer biopsy device (abstract) teaches:
a casing having a rear wall and a continuous sidewall extending from a peripheral edge of said rear wall and a front wall opposite said rear wall, said rear wall, said sidewall, and said front wall, together, defining an interior area ([0005]; [0101]-[0103], device 700 includes a casing (housing 712) with a rear wall, front wall, and sidewall that form an interior area as depicted in figures 22-23 and 28-31; [0104]-[0115], further detail the device 700 and associated elements),
said casing having a bottom face that defines an outlet proximate said front wall ([0005]; [0101]-[0103], device 700 includes a casing (housing 712) with a end cap 714 and block 716 that forms a bottom face proximate said front wall as depicted in figures 22-23 and 28-31; [0104]-[0115], further detail the device 700 and associated elements);
a penetration assembly positioned in said interior area that defines a channel and has a needle that is slidable between a retracted configuration positioned entirely in said channel and a deployed configuration extending through said outlet and positioned partially outside of said interior area ([0101]-[0104], device 700 includes a tubular shaft 706 with needle housing 708 that forms a penetration assembly within the interior area of device 700 housing 712, that provides for the needle to be slidable between a retracted configuration (figure 28) entirely in said channel and a deployed configuration extending throughout the outlet and partially outside the interior area (figure 30); [0105], inner sheath 750 enables retraction of the needle assembly 760 from a deployed state back to a retracted state; [0106]-[0109]; [0110], needle is positioned in a retracted configuration as in figure 28; [0111]; [0112]-[0114], needle is provided in a deployed position outside of the interior area as in figure 30);
a sonograph assembly having at least one sensor pad positioned on a bottom face of said casing and adjacent said outlet, said sonograph assembly being in data communication with an electronic sonograph module ([0101]-[0104], device 700 includes a ultrasonic probe 710 with a pair of sensors 718a and 718b that are positioned on a bottom of the housing 712 (see figures 22-23 and 28-31) and adjacent to the needle path (outlet) (see figure 16 and figure 26) and surrounding both sides of the central opening 720. Ultrasonic probe 710 therefore forms the sonograph assembly with at least one sensor pad (sensor 718a) and in communication with the ultrasound processor (sonograph module); [0105]-[0114], see also for further detail on device 700 configuration);
a display positioned on a top face of said casing and in data communication with said sonograph module ([0101]-[0103], device 700 includes a display 702 that is configured in electrical (data) communication with the ultrasonic probe 710, in which the ultrasound information is displayed on the display. This forms a teaching to the display on the top face of the casing (see figures 22-23 and 28-31), and communication with the sonograph (ultrasound probe 710); see also [0104]-[0115], further detail the device 700 and associated elements);
an actuator assembly positioned on said casing that includes in input member proximate said top face and a linkage extending between said input member and said needle, said linkage being slidable so as to cause said needle to move from said retracted configuration to said deployed configuration when said input member is actuated by a user ([0101]-[0106]; [0107], collar or slider 782 forms an input member proximate said top face of housing 712 and includes a linkage attached to tubular shaft 706 that provides for axial movement of the needle assembly 760 based upon sliding movement of the slider 782. This attachment forms a linkage that is also slidable within the interior of the housing for movement of the needle from the retracted configuration to the deployed configuration. [0108], needle actuators 788 and 790 in conjunction with the needle assembly 760 and the slider 782 provide for the actuator assembly components to enable the movement of the needle from the retracted to the deployed position; [0109]-[0115], further detail the device 700 and associated elements).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas to incorporate the casing with an interior actuated penetration assembly, an ultrasound transducer on a bottom face, and a display on a top face as taught by Grim because it provides for a sterilely housed needle deployment system with an integrated display screen for more accurate targeting of a region of interest (Grim, [0007]; [0062]). This provides for better ergonomics for physicians using the device, without having to look at an external screen when positioning the needle. This leads to more efficient procedures and less risk of unwanted mistargeting of the needle.
Regarding claim 2, the combined references of Blaivas and Grim teach all of the limitations of claim 1. Primary reference Blaivas further fails to teach:
wherein said actuator assembly is an actuation slider defining a slot along which said input member is selectively slidable so as to urge said CVC relative to said deployed or retracted configurations, respectively
However, the analogous art of Grim of an ultrasound-guided needle introducer biopsy device (abstract) teaches:
wherein said actuator assembly is an actuation slider defining a slot along which said input member is selectively slidable so as to urge said needle relative to said deployed or retracted configurations, respectively ([0105]-[0107], collar or slider 782 forms an input member proximate said top face of housing 712 and includes a linkage attached to tubular shaft 706 that provides for axial movement of the needle assembly 760 based upon sliding movement of the slider 782. This attachment forms a slot within the housing defined by channels 756a and 756b in the outer surface, which forms a slot upon which the arms 780a and 780b traverse in connection with the slider 782 and actuation assembly to move the needle between the retracted and deployed states; see also [0101]-[0104] and [0108]-[0115]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas and Grim to incorporate the slot upon which the sliding input member is moved as taught by Grim because it enables direct connection between an external slider moveable by a user and the internal actuation components configured to retract and deploy the injection assembly (Grim, [0101]-[0107]). This provides for efficient user control, leading to more precise deployment of the device to a target region of interest.
Regarding claim 3, the combined references of Blaivas and Grim teach all of the limitations of claim 2. Primary reference Blaivas further fails to teach:
wherein: said input member is a slider button;
said linkage includes at least one lever coupled at one end to said slider button and coupled at another end to said CVC
However, the analogous art of Grim of an ultrasound-guided needle introducer biopsy device (abstract) teaches:
wherein: said input member is a slider button ([0101]-[0106]; [0107], collar or slider 782 forms an input member proximate said top face of housing 712 and includes a linkage attached to tubular shaft 706 that provides for axial movement of the needle assembly 760 based upon sliding movement of the slider 782. Slider 782 forms a slider button; [0108]-[0115]);
said linkage includes at least one lever coupled at one end to said slider button and coupled at another end to said needle ([0101]-[0106]; [0107], collar or slider 782 is connected via arm 780a which forms a lever coupled to one end of the slider button and coupled to the needle assembly 764 and needle 762, which teaches to the CVC catheter in the combined invention; see also [0108]-[0115]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas and Grim to incorporate the slider button with a lever linkage to the needle assembly as taught by Grim because it enables direct connection between an external slider moveable by a user and the internal actuation components configured to retract and deploy the injection assembly (Grim, [0101]-[0107]). This provides for efficient user control, leading to more precise deployment of the device to a target region of interest.
Regarding claim 4, the combined references of Blaivas and Grim teach all of the limitations of claim 1. Primary reference Blaivas further teaches:
said CVC being positioned in said needle guide groove when said CVC is in said deployed configuration so as to penetrate a blood vessel identified by said sonograph module ([0043], catheter placement; [0047], advancement and retraction of the cannula (analogous to catheter for CVC procedure) during procedures; [0052], advancement and retraction; [0055], advancement and retraction of cannula system; [0058], injector for introduction of catheter and retraction of needle in and out of the assembly; [0064], central catheter lines; [0083], CVC catheter procedure for introduction into a patient using the introducer device; [0094]-[0095]; [0100], includes a introducer in conjunction with the transducer 135 (Sensor pad) for introduction into a blood vessel identified by the ultrasound image and imaging module; [0106]-[0110], needle/cannula retraction and use of cartridge 90 for deployment as in figures 40-42; [0111], introduced catheter into the patient).
Primary reference Blaivas further fails to teach:
wherein said bottom face of said casing defines a needle guide groove in-line with said at least one sensor pad
However, the analogous art of Grim of an ultrasound-guided needle introducer biopsy device (abstract) teaches:
wherein said bottom face of said casing defines a needle guide groove in-line with said at least one sensor pad ([0103], central opening 720 forms a needle guide groove in line with ultrasonic sensors 718a and 718b)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas and Grim to incorporate the needle guide groove as taught by Grim because it provides for a sterilely housed needle deployment system with an integrated display screen correlated to a central groove for more accurate targeting of a region of interest (Grim, [0007]; [0062]). This provides for better ergonomics for physicians using the device, without having to look at an external screen when positioning the needle. This leads to more efficient procedures and less risk of unwanted mistargeting of the needle.
Regarding claim 5, the combined references of Blaivas and Grim teach all of the limitations of claim 1. Primary reference Blaivas further fails to teach:
wherein: said at least one sensor pad includes a pair of sensor pads positioned adjacent one another and defining a space between said pair of sensor pads;
said casing defines a needle guide groove that is in-line with and extends through said space between said sensor pads; and
said CVC is positioned in said needle guide groove when said CVC is in said deployed configuration so as to penetrate a blood vessel identified by said sonograph module
However, the analogous art of Grim of an ultrasound-guided needle introducer biopsy device (abstract) teaches:
wherein: said at least one sensor pad includes a pair of sensor pads positioned adjacent one another and defining a space between said pair of sensor pads ([0103], central opening 720 forms a needle guide groove in line with ultrasonic sensors 718a and 718b as a pair of sensor pads, see figure 26; see also [0104]-[0115], figures 22-23 and 28-31);
said casing defines a needle guide groove that is in-line with and extends through said space between said sensor pads ([0103], central opening 720 forms a needle guide groove in line with ultrasonic sensors 718a and 718b, see figure 26; see also [0104]-[0115], figures 22-23 and 28-31); and
said needle is positioned in said needle guide groove when said needle is in said deployed configuration so as to penetrate a blood vessel identified by said sonograph module ([0103], central opening 720 forms a needle guide groove in line with ultrasonic sensors 718a and 718b, see figure 26; see also [0104]-[0115], figures 22-23 and 28-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas and Grim to incorporate the needle guide groove with sensor pads as taught by Grim because it provides for a sterilely housed needle deployment system with an integrated display screen correlated to a central groove for more accurate targeting of a region of interest (Grim, [0007]; [0062]). This provides for better ergonomics for physicians using the device, without having to look at an external screen when positioning the needle. This leads to more efficient procedures and less risk of unwanted mistargeting of the needle.
Regarding claim 6, the combined references of Blaivas and Grim teach all of the limitations of claim 4. Primary reference Blaivas further fails to teach:
wherein said channel is oriented in a downward angular configuration between a proximal end proximate said linkage and a distal end adjacent said at least one sensor pad
However, the analogous art of Grim of an ultrasound-guided needle introducer biopsy device (abstract) teaches:
wherein said channel is oriented in a downward angular configuration between a proximal end proximate said linkage and a distal end adjacent said at least one sensor pad ([0101]-[0104], device 700 includes a tubular shaft 706 with needle housing 708 that forms a penetration assembly within the interior area of device 700 housing 712, that provides for the needle to be slidable between a retracted configuration (figure 28) entirely in said channel and a deployed configuration extending throughout the outlet and partially outside the interior area (figure 30). The channel is oriented downwards towards the outlet port at 720, which forms a distal end adjacent to the ultrasonic sensor pads 718a and 718b; [0105], inner sheath 750 enables retraction of the needle assembly 760 from a deployed state back to a retracted state; [0106]-[0109]; [0110], needle is positioned in a retracted configuration as in figure 28; [0111]; [0112]-[0114], needle is provided in a deployed position outside of the interior area as in figure 30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas and Grim to incorporate the needle guide channel as taught by Grim because it provides for a sterilely housed needle deployment system with an integrated display screen correlated to a central channel for more accurate targeting of a region of interest based upon the known needle angle relative to the ultrasound system (Grim, [0007]; [0062]). This provides for better ergonomics for physicians using the device, while working with a screen for positioning the needle. This leads to more efficient procedures and less risk of unwanted mistargeting of the needle.
Regarding claim 7, the combined references of Blaivas and Grim teach all of the limitations of claim 1. Primary reference Blaivas further fails to teach:
wherein said CVC includes a hub that is operatively coupled to said input member of said slider assembly and a needle coupled to and extending forwardly away from said hub
However, the analogous art of Grim of an ultrasound-guided needle introducer biopsy device (abstract) teaches:
wherein said CVC includes a hub that is operatively coupled to said input member of said slider assembly and a needle coupled to and extending forwardly away from said hub ([0106]-[0107], needle subassembly 764 as in figure 23 forms a hub that is coupled to the input member (slider 782) via the arms 780a and 780b. This is also coupled to the needle 762 extending forward away from the hub to the tissue of interest; see also [0101]-[0105] and [0108]-[0114] and figures 22 and 28-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas and Grim to incorporate the needle hub as taught by Grim because it provides for a sterilely housed needle deployment system with exterior connection to a central groove for more accurate targeting of a region of interest (Grim, [0007]; [0062]). This provides for better ergonomics for physicians using the device for to more efficient procedures and less risk of unwanted mistargeting of the needle.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Blaivas, in view of Grim as applied to claim 7 above, and further in view of Gill et al. (U.S. Pub. No. 20120211006) hereinafter Gill.
Regarding claim 8, the combined references of Blaivas and Grim teach all of the limitations of claim 7. Primary reference Blaivas further fails to teach:
further comprising a solenoid positioned along said channel that is operative to move between an extended configuration that prevents movement of said hub in said channel and a released configuration that allows said hub to move in said channel according to downstream movement of said input member
However, the analogous art of Gill of a catheter insertion device for automatic deployment to a tissue of interest (abstract) teaches:
further comprising a solenoid positioned along said channel that is operative to move between an extended configuration that prevents movement of said hub in said channel and a released configuration that allows said hub to move in said channel according to downstream movement of said input member ([0133], locking pin retraction solenoid forms an extended and released configuration that prevents or allows movement of the hub containing the insertion needle within the overall housing; [0147]; [0154]; [0159]; [0183], locking pin retraction solenoid; figure 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas and Grim to incorporate the solenoid that locks or releases movement of the hub containing the needle assembly as taught by Gill because it enables a fixing of the needle assembly in the extended configuration without movement, and an automatic retraction to a movement position based upon solenoid activation between states (Gill, [0133]). This enables quick activation of locking of the needle to enable penetration into a target tissue of interest without the needle accidentally retracting back into the device leading to a inaccurate placement.
Regarding claim 9, the combined references of Blaivas and Grim teach all of the limitations of claim 7. Primary reference Blaivas further fails to teach:
further comprising a solenoid positioned along said channel that is operative to move between an extended configuration that holds said CVC at said retracted configuration and a released configuration that allows said CVC to move to said deployed configuration according to downstream movement of said input member
However, the analogous art of Gill of a catheter insertion device for automatic deployment to a tissue of interest (abstract) teaches:
further comprising a solenoid positioned along said channel that is operative to move between an extended configuration that holds said needle at said retracted configuration and a released configuration that allows said needle to move to said deployed configuration according to downstream movement of said input member ([0131], needle retraction solenoid provides for movement of the needle from a retracted to a deployed configuration with the activation or deactivation of the solenoid; [0139]-[0140]; [0146]; [0152]; [0155]; [0183]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas and Grim to incorporate the solenoid that activates movement of the needle assembly as taught by Gill because it enables a movement of the needle assembly in the extended configuration or retracted configuration with a simple solenoid activation between states (Gill, [0131]; [0183]). This enables quick activation movement, which leads to more efficient procedures.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Blaivas, in view of Grim as applied to claim 1 above, and further in view of Lenihan et al. (U.S. Pub. No. 20190275293) hereinafter Lenihan.
Regarding claim 10, the combined references of Blaivas and Grim teach all of the limitations of claim 1. Primary reference Blaivas further fails to teach:
wherein:
said bottom face of said casing defines a recessed area; and
the blood vessel penetration device further comprising a thermometer removably seated in said recessed area
However, the analogous art of Lenihan of a catheter system for targeting a tubular body (abstract) teaches:
wherein:
said bottom face of said casing defines a recessed area ([0156], figure 3, the lumen exit port in which hollow needle transits forms a recessed area at a bottom face of the launching device 10); and
the blood vessel penetration device further comprising a thermometer removably seated in said recessed area ([0156], figure 3, the temperature sensor as sensor 19 on hollow needle 17 forms a removably seated thermometer in the recessed area, as it is attached to the needle that sits in the recessed area and is removed when the needle is extended or retracted from the region).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas and Grim to incorporate the temperature sensor as taught by Lenihan because it enables additional sensing information of the target region of interest to further determine patient health and the success potential of an interventional procedure (see Lenihan, [0156]). This leads to improved procedures and better clinical outcomes.
Claims 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Blaivas, in view of Grim, in further view of Lenihan.
Regarding claim 11, primary reference Blaivas teaches:
A sonographically-aided blood vessel penetration device (abstract), comprising:
a casing ([0066]-[0067], cartridge 90 includes needle/cannula introducer and forms a casing for the introducer; [0106]-[0109], figures 40-42 include the cartridge 90 which forms a casing around the cannula/catheter system)
a penetration assembly that defines a channel and has a central venous catheter (CVC) that is slidable between a retracted configuration and a deployed configuration ([0043], catheter placement; [0047], advancement and retraction of the cannula (analogous to catheter for CVC procedure) during procedures; [0052], advancement and retraction; [0055], advancement and retraction of cannula system; [0058], injector for introduction of catheter and retraction of needle in and out of the assembly; [0064], central catheter lines; [0083], CVC catheter procedure for introduction into a patient using the introducer device; [0094]-[0095]; [0106]-[0110], needle/cannula retraction and use of cartridge 90 for deployment as in figures 40-42; [0111], introduced catheter into the patient)
a sonograph assembly adjacent said outlet, said sonograph assembly being in data communication with an electronic sonograph module that is configured to detect a blood vessel ([0043]-[0050], ultrasound transducer forms a sonograph assembly with a sensor pad (transducer element) located adjacent to the needle outlet and in data communication with ultrasound electronics (sonograph module); [0058], ultrasound probe; [0062]-[0065], ultrasound transceiver housing; [0068]-[0070], transducer base 16 of ultrasound transceiver housing 12 forms the sensor pad adjacent to the outlet; [0080]-[0085]; figures 15-20; [0115]);
Primary reference Blaivas fails to teach:
a casing having a rear wall and a continuous sidewall extending from a peripheral edge of said rear wall and a front wall opposite said rear wall, said rear wall, said sidewall,
said casing having a bottom face that defines an outlet proximate said front wall;
a penetration assembly positioned in said interior area that defines a channel and has a central venous catheter (CVC) that is slidable between a retracted configuration positioned entirely in said channel and a deployed configuration extending through said outlet and positioned partially outside of said interior area;
a sonograph assembly having a pair of sensor pads positioned adjacent one another on said bottom face of said casing adjacent said outlet, said sonograph assembly being in data communication with an electronic sonograph module that is configured to detect a blood vessel;
a display positioned on a top face of said casing and in data communication with said sonograph module and operative to display said detected blood vessel;
an actuator assembly positioned on said top face of said casing that is configured so as to move said CVC from said retracted configuration to said deployed configuration when actuated by a user
However, the analogous art of Grim of an ultrasound-guided needle introducer biopsy device (abstract) teaches:
a casing having a rear wall and a continuous sidewall extending from a peripheral edge of said rear wall and a front wall opposite said rear wall, said rear wall, said sidewall ([0005]; [0101]-[0103], device 700 includes a casing (housing 712) with a rear wall, front wall, and sidewall that form an interior area as depicted in figures 22-23 and 28-31; [0104]-[0115], further detail the device 700 and associated elements),
said casing having a bottom face that defines an outlet proximate said front wall ([0005]; [0101]-[0103], device 700 includes a casing (housing 712) with a end cap 714 and block 716 that forms a bottom face proximate said front wall as depicted in figures 22-23 and 28-31; [0104]-[0115], further detail the device 700 and associated elements);
a penetration assembly positioned in said interior area that defines a channel and has a needle that is slidable between a retracted configuration positioned entirely in said channel and a deployed configuration extending through said outlet and positioned partially outside of said interior area ([0101]-[0104], device 700 includes a tubular shaft 706 with needle housing 708 that forms a penetration assembly within the interior area of device 700 housing 712, that provides for the needle to be slidable between a retracted configuration (figure 28) entirely in said channel and a deployed configuration extending throughout the outlet and partially outside the interior area (figure 30); [0105], inner sheath 750 enables retraction of the needle assembly 760 from a deployed state back to a retracted state; [0106]-[0109]; [0110], needle is positioned in a retracted configuration as in figure 28; [0111]; [0112]-[0114], needle is provided in a deployed position outside of the interior area as in figure 30);
a sonograph assembly having a pair of sensor pads positioned adjacent one another on said bottom face of said casing adjacent said outlet, said sonograph assembly being in data communication with an electronic sonograph module that is configured to detect a target ([0101]-[0104], device 700 includes a ultrasonic probe 710 with a pair of sensors 718a and 718b that are positioned on a bottom of the housing 712 (see figures 22-23 and 28-31) and adjacent to the needle path (outlet) (see figure 16 and figure 26) and surrounding both sides of the central opening 720. Ultrasonic probe 710 therefore forms the sonograph assembly with at least one sensor pad (sensor 718a) and in communication with the ultrasound processor (sonograph module); [0105]-[0114], see also for further detail on device 700 configuration);
a display positioned on a top face of said casing and in data communication with said sonograph module and operative to display said detected target ([0101]-[0103], device 700 includes a display 702 that is configured in electrical (data) communication with the ultrasonic probe 710, in which the ultrasound information is displayed on the display. This forms a teaching to the display on the top face of the casing (see figures 22-23 and 28-31, and communication with the sonograph (ultrasound probe 710); see also [0104]-[0115], further detail the device 700 and associated elements);
an actuator assembly positioned on said top face of said casing that is configured so as to move said needle from said retracted configuration to said deployed configuration when actuated by a user ([0101]-[0106]; [0107], collar or slider 782 forms an input member proximate said top face of housing 712 and includes a linkage attached to tubular shaft 706 that provides for axial movement of the needle assembly 760 based upon sliding movement of the slider 782. This attachment forms a linkage that is also slidable within the interior of the housing for movement of the needle from the retracted configuration to the deployed configuration. [0108], needle actuators 788 and 790 in conjunction with the needle assembly 760 and the slider 782 provide for the actuator assembly components to enable the movement of the needle from the retracted to the deployed position; [0109]-[0115], further detail the device 700 and associated elements).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas to incorporate the casing with an interior actuated penetration assembly, an ultrasound transducer on a bottom face, and a display on a top face as taught by Grim because it provides for a sterilely housed needle deployment system with an integrated display screen for more accurate targeting of a region of interest (Grim, [0007]; [0062]). This provides for better ergonomics for physicians using the device, without having to look at an external screen when positioning the needle. This leads to more efficient procedures and less risk of unwanted mistargeting of the needle.
Primary reference Blaivas further fails to teach:
wherein:
said bottom face of said casing defines a recessed area; and
the blood vessel penetration device further comprising a thermometer removably seated in said recessed area
However, the analogous art of Lenihan of a catheter system for targeting a tubular body (abstract) teaches:
wherein:
said bottom face of said casing defines a recessed area ([0156], figure 3, the lumen exit port in which hollow needle transits forms a recessed area at a bottom face of the launching device 10); and
the blood vessel penetration device further comprising a thermometer removably seated in said recessed area ([0156], figure 3, the temperature sensor as sensor 19 on hollow needle 17 forms a removably seated thermometer in the recessed area, as it is attached to the needle that sits in the recessed area and is removed when the needle is extended or retracted from the region).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas and Grim to incorporate the temperature sensor as taught by Lenihan because it enables additional sensing information of the target region of interest to further determine patient health and the success potential of an interventional procedure (see Lenihan, [0156]). This leads to improved procedures and better clinical outcomes.
Regarding claim 12, the combined references of Blaivas, Grim, and Lenihan teach all of the limitations of claim 11. Primary reference Blaivas further fails to teach:
wherein said actuator assembly is an actuation slider that defines a slot and includes a slider button that is selectively slidable along said slot
which is operatively coupled via a linkage to said CVC so as to urge said CVC relative to said deployed or retracted configurations, respectively
However, the analogous art of Grim of an ultrasound-guided needle introducer biopsy device (abstract) teaches:
wherein said actuator assembly is an actuation slider that defines a slot and includes a slider button that is selectively slidable along said slot ([0105]-[0107], collar or slider 782 forms an input member proximate said top face of housing 712 and includes a linkage attached to tubular shaft 706 that provides for axial movement of the needle assembly 760 based upon sliding movement of the slider 782. This attachment forms a slot within the housing defined by channels 756a and 756b in the outer surface, which forms a slot upon which the arms 780a and 780b traverse in connection with the slider 782 and actuation assembly to move the needle between the retracted and deployed states. Slider 782 forms a slider button; see also [0101]-[0104] and [0108]-[0115])and
which is operatively coupled via a linkage to said needle so as to urge said needle relative to said deployed or retracted configurations, respectively ([0101]-[0106]; [0107], collar or slider 782 forms an input member proximate said top face of housing 712 and includes a linkage attached to tubular shaft 706 that provides for axial movement of the needle assembly 760 based upon sliding movement of the slider 782. This attachment forms a linkage that is also slidable within the interior of the housing for movement of the needle from the retracted configuration to the deployed configuration. [0108], needle actuators 788 and 790 in conjunction with the needle assembly 760 and the slider 782 provide for the actuator assembly components to enable the movement of the needle from the retracted to the deployed position; [0109]-[0115], further detail the device 700 and associated elements).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas, Grim, and Lenihan to incorporate the slider button with a lever linkage to the needle assembly as taught by Grim because it enables direct connection between an external slider moveable by a user and the internal actuation components configured to retract and deploy the injection assembly (Grim, [0101]-[0107]). This provides for efficient user control, leading to more precise deployment of the device to a target region of interest.
Regarding claim 13, the combined references of Blaivas, Grim, and Lenihan teach all of the limitations of claim 11. Primary reference Blaivas further fails to teach:
wherein:
said bottom face of said casing defines a needle guide groove that is in-line with and extends between said pair of sensor pads; and
said CVC is positioned in said needle guide groove when said CVC is in said deployed configuration so as to penetrate a blood vessel identified by said sonograph module
However, the analogous art of Grim of an ultrasound-guided needle introducer biopsy device (abstract) teaches:
said bottom face of said casing defines a needle guide groove that is in-line with and extends between said pair of sensor pads ([0103], central opening 720 forms a needle guide groove in line with ultrasonic sensors 718a and 718b, see figure 26; see also [0104]-[0115], figures 22-23 and 28-31); and
said needle is positioned in said needle guide groove when said needle is in said deployed configuration so as to penetrate a blood vessel identified by said sonograph module ([0103], central opening 720 forms a needle guide groove in line with ultrasonic sensors 718a and 718b, see figure 26; see also [0104]-[0115], figures 22-23 and 28-31)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas, Grim, and Lenihan to incorporate the needle guide groove with sensor pads as taught by Grim because it provides for a sterilely housed needle deployment system with an integrated display screen correlated to a central groove for more accurate targeting of a region of interest (Grim, [0007]; [0062]). This provides for better ergonomics for physicians using the device, without having to look at an external screen when positioning the needle. This leads to more efficient procedures and less risk of unwanted mistargeting of the needle.
Regarding claim 14, the combined references of Blaivas, Grim, and Lenihan teach all of the limitations of claim 12. Primary reference Blaivas further fails to teach:
wherein said channel is oriented in a downward angular configuration between a proximal end proximate said linkage and a distal end adjacent said pair of sensor pads
However, the analogous art of Grim of an ultrasound-guided needle introducer biopsy device (abstract) teaches:
wherein said channel is oriented in a downward angular configuration between a proximal end proximate said linkage and a distal end adjacent said pair of sensor pads ([0101]-[0104], device 700 includes a tubular shaft 706 with needle housing 708 that forms a penetration assembly within the interior area of device 700 housing 712, that provides for the needle to be slidable between a retracted configuration (figure 28) entirely in said channel and a deployed configuration extending throughout the outlet and partially outside the interior area (figure 30). The channel is oriented downwards towards the outlet port at 720, which forms a distal end adjacent to the ultrasonic sensor pads 718a and 718b; [0105], inner sheath 750 enables retraction of the needle assembly 760 from a deployed state back to a retracted state; [0106]-[0109]; [0110], needle is positioned in a retracted configuration as in figure 28; [0111]; [0112]-[0114], needle is provided in a deployed position outside of the interior area as in figure 30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas, Grim, and Lenihan to incorporate the needle guide channel as taught by Grim because it provides for a sterilely housed needle deployment system with an integrated display screen correlated to a central channel for more accurate targeting of a region of interest based upon the known needle angle relative to the ultrasound system (Grim, [0007]; [0062]). This provides for better ergonomics for physicians using the device, while working with a screen for positioning the needle. This leads to more efficient procedures and less risk of unwanted mistargeting of the needle.
Regarding claim 15, the combined references of Blaivas, Grim, and Lenihan teach all of the limitations of claim 11. Primary reference Blaivas further fails to teach:
wherein said CVC includes a hub that is operatively coupled to said slider button of said slider assembly and a needle coupled to and extending forwardly away from said hub
However, the analogous art of Grim of an ultrasound-guided needle introducer biopsy device (abstract) teaches:
wherein said needle includes a hub that is operatively coupled to said slider button of said slider assembly and a needle coupled to and extending forwardly away from said hub ([0106]-[0107], needle subassembly 764 as in figure 23 forms a hub that is coupled to the input member (slider 782) via the arms 780a and 780b. This is also coupled to the needle 762 extending forward away from the hub to the tissue of interest; see also [0101]-[0105] and [0108]-[0114] and figures 22 and 28-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas, Grim, and Lenihan to incorporate the needle hub as taught by Grim because it provides for a sterilely housed needle deployment system with exterior connection to a central groove for more accurate targeting of a region of interest (Grim, [0007]; [0062]). This provides for better ergonomics for physicians using the device for to more efficient procedures and less risk of unwanted mistargeting of the needle.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Blaivas, in view of Grim, in further view of Lenihan as applied to claim 15 above, and further in view of Gill.
Regarding claim 16, the combined references of Blaivas, Grim, and Lenihan teach all of the limitations of claim 15. Primary reference Blaivas further fails to teach:
further comprising a solenoid positioned along and adjacent to said channel that is operative to move between an extended configuration that prevents movement of said hub in said channel and a released configuration that allows said hub to move in said channel according to downstream movement of said input member
However, the analogous art of Gill of a catheter insertion device for automatic deployment to a tissue of interest (abstract) teaches:
further comprising a solenoid positioned along and adjacent to said channel that is operative to move between an extended configuration that prevents movement of said hub in said channel and a released configuration that allows said hub to move in said channel according to downstream movement of said input member ([0133], locking pin retraction solenoid forms an extended and released configuration that prevents or allows movement of the hub containing the insertion needle within the overall housing; [0147]; [0154]; [0159]; [0183], locking pin retraction solenoid; figure 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter introducer and ultrasound imaging assembly of Blaivas, Grim, and Lenihan to incorporate the solenoid that locks or releases movement of the hub containing the needle assembly as taught by Gill because it enables a fixing of the needle assembly in the extended configuration without movement, and an automatic retraction to a movement position based upon solenoid activation between states (Gill, [0133]). This enables quick activation of locking of the needle to enable penetration into a target tissue of interest without the needle accidentally retracting back into the device leading to an inaccurate placement.
Conclusion
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/SEAN A FRITH/Primary Examiner, Art Unit 3798