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 .
Specification
The disclosure is objected to because of the following informalities: in paragraphs 0012 and 0025, “causing” should be “causes” .
Appropriate correction is required.
Claim Objections
Claims 6, 8, and 19-20 are objected to because of the following informalities:
Claim 6, line 3 “causing” should be “causes”.
Claim 8, line 4 “the second” should be “the second position”.
Claim 19, line 3 “causing” should be “causes”.
Claim 20, line 5 “the second” should be “the second position”.
Appropriate correction is required.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20190021640) in view of Willybiro (US 20200230320 A1), further in view of Devgon (US 20220226615).
Regarding Claim 1, Burkholz discloses a vascular access system (Fig. 1A; Paragraph 0040) comprising: a catheter assembly (catheter assembly 14, Fig. 1A) comprising:
a catheter (catheter 16, Fig. 1A) and a near-patient access port (second port 26, Fig. 1A); and
a sensor probe delivery device (extension 10, Fig. 1A; Paragraph 0042) coupleable to the near-patient access port to enable access to the catheter via the catheter assembly (Figures 1A-1B; Paragraphs 0040-0041), the delivery device comprising:
a sensing probe assembly (Fig. 1A) comprising: a probe member (instrument 12, Fig. 1A; Paragraph 0042) including one or more sensors configured to measure one or more blood-related parameters (Paragraph 0042-- the probe may include one or more openings and/or one or more sensors… the sensors may measure one or more parameters and/or detect one or more elements related to, for example, diagnostic information, blood chemistry, pressure, flow rate, drug identification, microbes, placement of an implantable stent, in-vein catheter tip stabilization feature, or other device, etc….), the probe member having a distal end (Paragraph 0042, as sensors may be disposed near a distal tip of the probe) and a proximal end (end at which advancement tab 46 is coupled, Fig. 2A; Paragraph 0060);
a housing configured to movably receive at least a portion of the sensing probe assembly within an inner volume thereof (housing 28, Fig. 2A and 2D);
a lock configured to couple the housing to the near patient access port (Coupling mechanism 30; paragraph 0048-0049); and
an advancement member (advancement tab 46, Fig. 2A) configured to move relative to the housing to move the sensing probe assembly between a first position, in which a distal end of the probe member is disposed within the housing or the lock (Fig. 2A), and a second position in which a distal end of the probe member is disposed beyond the distal end portion of the housing and the lock and into the catheter or out past a distal tip of the catheter (Fig. 2D); wherein, with the sensing probe assembly in the second position, the probe member is positioned to measure the one or more blood-related parameters (Paragraph 0042).
Burkholz generally teaches that the probe member may connect to an electrical connector (Paragraph 0017, 0057, 0066).
However, Burkholz fails to explicitly disclose an electrical connector positioned proximally from the probe member, the electrical connector configured to operably connect to an external device.
Willybiro in the same field of endeavor of intravenous devices having a plurality of sensors to provide measurements of patient parameters (Paragraph 0004), teaches a device having an electrical connector ( printed circuit board (PCB) 110 and means of coupling the PCB to the sensors 112, Fig. 1; Paragraph 0019-0028, 0031-- sensors 112 may be communicatively coupled to the PCB 110, physically coupled to the PCB 110, or both communicatively and physically coupled to the PCB 110) positioned proximally from a probe member (PCB 110 is positioned proximally from sensor 112 which demonstrates the position of the probe member, Fig. 1; Paragraphs 0018-0020), the electrical connector configured to operably connect to an external device (Paragraph 0028-0031).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vascular access system of Burkholz to further include an electrical connector positioned proximally from the probe member, the electrical connector configured to operably connect to an external device, as taught by Willybiro, in order to predictably improve the device by allowing for continuous real-time patient monitoring, which would improve the ability of a medical provider to provide prompt care to a patient having an adverse reaction to a medication or otherwise in need of treatment (Willybiro, Paragraph 0005). Furthermore, this may be seen as motivated by Burkholz’s disclosure of the device being connected to an electrical connector or other instrument (Paragraph 0017, 0057, 0066) such that Burkholz demonstrates that such a modification would have been obvious at the time of filing.
However, the combination of Burkholz and Willybiro fails to disclose the housing comprising a detachable portion separable from a remainder of the housing.
Devgon, in the same field of endeavor of fluid transfer medical devices (Paragraph 0002), teaches a device having a housing (introducer 210, Fig. 3) comprising a detachable portion separable from a remainder of the housing (Paragraph 0066, as first member 220 and second member 230 may be coupled via a mechanical fastener, one or more tabs, snaps, pins, and/or the like).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vascular access system of Burkholz to further include the housing comprising a detachable portion separable from a remainder of the housing, as taught by Devgon, in order to predictably improve the device by reducing undesirable variations in the shape and/or size of the inner surfaces of the housing, which in some instances, can reduce a likelihood of kinks, bends, and/or deformations of the corresponding catheter, as well as can allow an inner surface of the housing to form a tortuous shape that would otherwise present challenges when manufacturing the housing from a single workpiece (Devgon, Paragraph 0066).
Regarding Claim 2, the combination of Burkholz, Willybiro, and Devgon discloses the vascular access system of claim 1. Burkholz additionally teaches wherein the housing comprises a coupler provided at a distal end portion thereof (sleeve 55, Figures 1, 3, 2H-2I), the coupler configured to mate with the lock (Coupling mechanism 30; paragraph 0064-0065) or formed integrally with a portion of the lock (Coupling mechanism 30; paragraph 0064-0065).
However, Burkholz fails to explicitly disclose that the detachable portion of the housing is configured to disconnect from the coupler.
Devgon teaches that the detachable portion of the housing is configured to disconnect from a coupler (coupler 216, Figures 4, 5, and 11; Paragraphs 0066 and 0069, as either of first member 220 and second member 230 is coupled to the remaining of the two via mechanical fasteners, tabs, snaps, pins, and/or the like, yielding it detachable from the remaining member, and therefore, the portion of it that forms coupler 216).
It would have been obvious to one of ordinary skill in the art before the priority date to modify the vascular access system of Burkholz to further include that the detachable portion of the housing is configured to disconnect from the coupler, as taught by Devgon, in order to predictably improve the device by reducing undesirable variations in the shape and/or size of the inner surfaces of the housing, which in some instances, can reduce a likelihood of kinks, bends, and/or deformations of the corresponding catheter, as well as can allow an inner surface of the housing to form a tortuous shape that would otherwise present challenges when manufacturing the housing from a single workpiece (Devgon, Paragraph 0066).
Regarding Claim 3, the combination of Burkholz, Willybiro, and Devgon discloses the vascular access system of claim 2. However, Burkholz fails to explicitly disclose that the detachable portion of the housing is configured to disconnect from the coupler via a twist-type disconnection.
Devgon teaches that the detachable portion of the housing is configured to disconnect from the coupler via a twist-type disconnection (Paragraph 0074, as coupler 241 engages coupler 216 of introducer 210 by a threaded coupling).
It would have been obvious to one of ordinary skill in the art before the priority date to modify the vascular access system of Burkholz to further include that the detachable portion of the housing is configured to disconnect from the coupler, as taught by Devgon, in order to predictably improve the device by reducing undesirable variations in the shape and/or size of the inner surfaces of the housing, which in some instances, can reduce a likelihood of kinks, bends, and/or deformations of the corresponding catheter, as well as can allow an inner surface of the housing to form a tortuous shape that would otherwise present challenges when manufacturing the housing from a single workpiece (Devgon, Paragraph 0066) and where the twist-type disconnection would physically and fluidically couple the portions of the housing to one another and to any suitable intermediate device or adapter to improve the functionality of the device (Devgon, Paragraph 0074).
Regarding Claim 4, the combination of Burkholz, Willybiro, and Devgon discloses the vascular access system of claim 2. However, Burkholz fails to explicitly disclose the detachable portion comprises a splittable housing including a pair of detachable housing portions that separate off from the coupler.
Devgon teaches the detachable portion comprises a splittable housing including a pair of detachable housing portions that separate off from the coupler (Figures 4-5 and 11; Paragraph 0066, as first member 220 and second member 230 may be coupled via a mechanical fastener, one or more tabs, snaps, pins, and/or the like; Paragraph 0069, as the distal end portion 222 of the first member 220 and the distal end portion 232 of the second member 230 collectively form the coupler 216 at the distal end portion 212 of the introducer 210; Paragraph 0074, as coupler 241 engages coupler 216 of introducer 210 by a threaded coupling).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vascular access system of Burkholz to further include that the detachable portion comprises a splittable housing including a pair of detachable housing portions that separate off from the coupler, as taught by Devgon, in order to predictably improve the device by reducing undesirable variations in the shape and/or size of the inner surfaces of the housing, which in some instances, can reduce a likelihood of kinks, bends, and/or deformations of the corresponding catheter, as well as can allow an inner surface of the housing to form a tortuous shape that would otherwise present challenges when manufacturing the housing from a single workpiece (Devgon, Paragraph 0066).
Regarding Claim 5, the combination of Burkholz, Willybiro, and Devgon discloses the vascular access system of claim 2. Burkholz generally teaches the sensing probe assembly may comprise a connector portion, wherein the connector portion is positioned adjacent the coupler when the sensing probe assembly is in the second position (Paragraph 0057, 0066—may include a luer fitting 40; see movement of the Luer fitting 40 in figs. 2A-2D). However, Burkholz fails to explicitly disclose that the sensing probe assembly comprises a connector portion including: a fitting configured to secure the proximal end of the probe member therein; and a flange member joined with the fitting; wherein the connector portion is positioned adjacent the coupler when the sensing probe assembly is in the second position, with the connector portion retained in the coupler.
Devgon teaches a probe assembly (Fig. 5) that comprises a connector portion (portion including actuator 270 that connects to proximal end portion 261 of catheter 260, Fig. 5) including: a fitting configured to secure the proximal end of the probe member therein (second portion 275 of actuator 270, Fig. 5); and a flange member joined with the fitting (wall 277, Fig. 17); wherein the connector portion is positioned adjacent the coupler when the probe assembly is in a second position, with the connector portion retained in the coupler (coupler 216, Fig. 28-29).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vascular access system of Burkholz to further include that the sensing probe assembly comprises a connector portion including: a fitting configured to secure the proximal end of the probe member therein; and a flange member joined with the fitting; wherein the connector portion is positioned adjacent the coupler when the sensing probe assembly is in the second position, with the connector portion retained in the coupler, as taught by Devgon, as a matter of simple substitution of parts known in the art, in this case the substitution of the luer fitting of Burkholz for the fitting and flange connection of Devgon.
Regarding Claim 6, the combination of Burkholz, Willybiro, and Devgon discloses the vascular access system of claim 5. Burkholz generally teaches that movement of the advancement member relative to the housing causes a corresponding movement of the sensing probe assembly (See Figs. 2A-2D). However, Burkholz fails to explicitly disclose that the advancement member is coupled with the flange of the connector portion, such that movement of the advancement member relative to the housing causes a corresponding movement of the sensing probe assembly.
Devgon teaches an advancement member coupled with the flange of the connector portion (engagement member 272, Fig. 17), such that movement of the advancement member relative to the housing causes a corresponding movement of the probe assembly (Figures 22 and 25).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vascular access system of Burkholz to further include that the advancement member is coupled with the flange of the connector portion, such that movement of the advancement member relative to the housing causes a corresponding movement of the sensing probe assembly, as taught by Devgon, as a matter of simple substitution of parts known in the art, in this case the substitution of the luer fitting of Burkholz for the fitting and flange connection of Devgon and additionally because Burkholz notes that the advancement tab may be disposed in any number of locations, including in alignment with the slot of the housing, to facilitate easy movement of the corresponding instrument (Burkholz, Paragraph 0060; Devgon, Figures 5 and 28).
Regarding Claim 7, the combination of Burkholz, Willybiro, and Devgon discloses the vascular access system of claim 5. Burkholz generally discloses that the electrical connector is positioned at the proximal end of the probe member and that the proximal end of the probe member and thus the electrical connector may extend out proximally from the advancement member (Paragraph 0017, 0057, 0066; proximal end of instrument 12 extends out proximally relative to the advancement tab 46, Figs. 2A-2D). However, Burkholz does not explicitly disclose wherein the electrical connector is joined to the connector portion and extends out proximally therefrom.
Willybiro teaches wherein the electrical connector (a printed circuit board (PCB) 110) is joined to a connector portion and extends out proximally therefrom (Fig. 1, the PCB 110 extends proximally via tubing 115 from a connector of the sensor probe assembly including the sensors 112; paragraph 0019-0020-- sensors 112 may be communicatively coupled to the PCB 110, physically coupled to the PCB 110, or both communicatively and physically coupled to the PCB 110).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vascular access system of Burkholz to further include the electrical connector is joined to the connector portion and extends out proximally therefrom, as taught by Willybiro, in order to predictably improve the device by allowing for continuous real-time patient monitoring, which would improve the ability of a medical provider to provide prompt care to a patient having an adverse reaction to a medication or otherwise in need of treatment (Willybiro, Paragraph 0005). Furthermore, this may be seen as motivated by Burkholz’s disclosure of the device being connected to an electrical connector or other instrument at a proximal end of a connector (Paragraph 0017, 0057, 0066) such that Burkholz demonstrates that such a modification would have been obvious at the time of filing.
Regarding Claim 8, the combination of Burkholz, Willybiro, and Devgon discloses the vascular access system of claim 7. Burkholz teaches the positioning of the connector portion (see luer fitting 40). However, Burkholz fails to explicitly disclose wherein the electrical connector is positioned within the housing when the sensing probe assembly is in each of the first position and the second position, with the electrical connector being accessible when the sensing probe assembly is in the second, upon disconnecting of the detachable portion.
Willybiro teaches the electrical connector is positioned within the housing when the sensing probe assembly is in each of the first position and the second position (Paragraph 0019-0020 where it is noted that a physical connection between the PCB and the sensors would extend through a housing), with the electrical connector being accessible when the sensing probe assembly is in the second, upon disconnecting of the detachable portion (Fig. 1A, the PCB 110 of the electrical connector would be accessible in any position of the sensing probe assembly).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vascular access system of Burkholz to further include wherein the electrical connector is positioned within the housing when the sensing probe assembly is in each of the first position and the second position, with the electrical connector being accessible when the sensing probe assembly is in the second, upon disconnecting of the detachable portion, as taught by Willybiro, in order to predictably improve the device by allowing for continuous real-time patient monitoring, which would improve the ability of a medical provider to provide prompt care to a patient having an adverse reaction to a medication or otherwise in need of treatment (Willybiro, Paragraph 0005). Furthermore, this may be seen as motivated by Burkholz’s disclosure of the device being connected to an electrical connector or other instrument at a proximal end of a connector (Paragraph 0017, 0057, 0066) such that Burkholz demonstrates that such a modification would have been obvious at the time of filing.
Regarding Claim 9, the combination of Burkholz, Willybiro, and Devgon discloses the vascular access system of claim 5. Burkholz teaches the positioning of the connector portion (see luer fitting 40). Willybiro additionally teaches wherein the sensing probe assembly comprises a wired extension joined to the connector portion and extending out proximally therefrom, and wherein the electrical connector is coupled to the wired extension at a proximal end thereof (Fig. 1, the PCB 110 extends proximally via tubing 115 from a connector of the sensor probe assembly including the sensors 112; paragraph 0019-0020-- sensors 112 may be communicatively coupled to the PCB 110, physically coupled to the PCB 110, or both communicatively and physically coupled to the PCB 110).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vascular access system of Burkholz to further include wherein the sensing probe assembly comprises a wired extension joined to the connector portion and extending out proximally therefrom, and wherein the electrical connector is coupled to the wired extension at a proximal end thereof, as taught by Willybiro, in order to predictably improve the device by allowing for continuous real-time patient monitoring, which would improve the ability of a medical provider to provide prompt care to a patient having an adverse reaction to a medication or otherwise in need of treatment (Willybiro, Paragraph 0005). Furthermore, this may be seen as motivated by Burkholz’s disclosure of the device being connected to an electrical connector or other instrument at a proximal end of a connector (Paragraph 0017, 0057, 0066) such that Burkholz demonstrates that such a modification would have been obvious at the time of filing.
Regarding Claim 10, the combination of Burkholz, Willybiro, and Devgon discloses the vascular access system of claim 9. Burkholz teaches the positioning of the connector portion (see luer 40), such that the connector portion is spaced apart from the coupler (coupling mechanism 30) when the sensing probe assembly is in the second position (See Fig. 2C-2D, where the connector portion 40 would be spaced some distance apart from the coupler 30 in the second position).
Willybiro teaches wherein with the electrical connector coupled to the proximal end of the wired extension (Fig. 1, the PCB 110 extends proximally via tubing 115 from a connector of the sensor probe assembly including the sensors 112; paragraph 0019-0020-- sensors 112 may be communicatively coupled to the PCB 110, physically coupled to the PCB 110, or both communicatively and physically coupled to the PCB 110).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vascular access system of Burkholz so that with the electrical connector is coupled to the proximal end of the wired extension, the electrical connector is spaced apart from the connector portion and the coupler when the sensing probe assembly is in the second position, as taught by Willybiro, in order to predictably improve the device by allowing for continuous real-time patient monitoring, which would improve the ability of a medical provider to provide prompt care to a patient having an adverse reaction to a medication or otherwise in need of treatment (Willybiro, Paragraph 0005). Furthermore, this may be seen as motivated by Burkholz’s disclosure of the device being connected to an electrical connector or other instrument at a proximal end of a connector (Paragraph 0017, 0057, 0066) such that Burkholz demonstrates that such a modification would have been obvious at the time of filing.
Regarding Claim 11, the combination of Burkholz, Willybiro, and Devgon discloses the vascular access system of claim 1. However, Burkholz fails to disclose a wireless module coupled to the electrical connector, the wireless module configured to: receive the one or more blood-related parameters from the sensing probe assembly; and analyze and display the one or more blood-related parameters and/or wirelessly transmit the one or more blood-related parameters to a processing device.
Willyboro additionally teaches a wireless module coupled to the electrical connector, the wireless module configured to: receive the one or more blood-related parameters from the sensing probe assembly; and analyze and display the one or more blood-related parameters and/or wirelessly transmit the one or more blood-related parameters to a processing device (Paragraph 0028, 0051-0052, 0054-0056-- In the embodiment where the processor is placed remote of the intravenous device 100, the processor may be included within a computing device communicatively coupled to the sensors of the PCB 110 via a network interface device formed on the intravenous device 100… The data provided by the pressure sensor, temperature sensor, optical sensor, and accelerometer may be used individually or in combination by the processor of the computing device in order to generate conclusions… A network interface device 342 of the intravenous device may communicate data from the sensors 334, 336, 338, 340 over the network 328 using a network interface device 320 of the computing device, and to a processor that executes or operates the IV device control module 332 as described herein… video display 310 of the computing device may be used by a clinician to track the condition of the patient, detect changes in the condition of the patient which may indicate deterioration, and ultimately send out alarms to the clinician or other HCP).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vascular access system of Burkholz to include a wireless module coupled to the electrical connector, the wireless module configured to: receive the one or more blood-related parameters from the sensing probe assembly; and analyze and display the one or more blood-related parameters and/or wirelessly transmit the one or more blood-related parameters to a processing device, as taught by Willybiro, in order to predictably improve the device by allowing for continuous real-time patient monitoring, which would improve the ability of a medical provider to provide prompt care to a patient having an adverse reaction to a medication or otherwise in need of treatment (Willybiro, Paragraph 0005). Furthermore, this may be seen as motivated by Burkholz’s disclosure of the device being connected to an electrical connector or other instrument at a proximal end of a connector (Paragraph 0017, 0057, 0066) such that Burkholz demonstrates that such a modification would have been obvious at the time of filing.
Regarding Claim 12, the combination of Burkholz, Willybiro, and Devgon discloses the vascular access system of claim 1. However, Burkholz fails to disclose a patient data cable coupled to the electrical connector and configured to transmit the one or more blood-related parameters to a processing device.
Willyboro additionally teaches a patient data cable coupled to the electrical connector and configured to transmit the one or more blood-related parameters to a processing device (Paragraph 0028, 0031 0051-0052, 0054-0057-- electrical lines 120 may be used to communicatively couple the PCB 110 and its associated sensors and network interface device with, for example, a computing device, a power source, or both … The data provided by the pressure sensor, temperature sensor, optical sensor, and accelerometer may be used individually or in combination by the processor of the computing device in order to generate conclusions… the intravenous device may be communicatively coupled to the processor 302 via a number of electrical lines 344. The electrical lines 344 may send and received signals to and from the processor 302).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vascular access system of Burkholz to include a patient data cable coupled to the electrical connector and configured to transmit the one or more blood-related parameters to a processing device, as taught by Willybiro, in order to predictably improve the device by allowing for continuous real-time patient monitoring, which would improve the ability of a medical provider to provide prompt care to a patient having an adverse reaction to a medication or otherwise in need of treatment (Willybiro, Paragraph 0005). Furthermore, this may be seen as motivated by Burkholz’s disclosure of the device being connected to an electrical connector or other instrument at a proximal end of a connector (Paragraph 0017, 0057, 0066) such that Burkholz demonstrates that such a modification would have been obvious at the time of filing.
Regarding Claim 13, the combination of Burkholz, Willybiro, and Devgon discloses the vascular access system of claim 1. Burkholz additionally teaches wherein the catheter assembly (catheter assembly 14, Fig. 1A) comprises: a catheter adapter (Catheter adapter 20) coupled to a proximal end of the catheter (catheter 16), the catheter adapter comprising an adapter port (adapter port 26); and a connector connected to the adapter port via an extension tube (connector 32 attached via extension tube 22), wherein the near patient access port is provided at a proximal end of the connector (see Fig. 1A).
Regarding claim 14, Burkholz discloses a method of using a vascular access system (paragraph 0006, 0040) the method comprising:
Providing a vascular access system (Fig. 1A; paragraph 0040) having a catheter assembly (catheter assembly 14, Fig. 1A) including a catheter (catheter 16, Fig. 1A) and a near-patient access port (second port 26, Fig. 1A); and
a sensor probe delivery device (extension 10, Fig. 1A; Paragraph 0042) coupleable to the near-patient access port to enable access to the catheter via the catheter assembly (Figures 1A-1B; Paragraphs 0040-0041), the delivery device comprising:
a sensing probe assembly (Fig. 1A) having a probe member (instrument 12, Fig. 1A; Paragraph 0042) including one or more sensors configured to measure one or more blood-related parameters (Paragraph 0042-- the probe may include one or more openings and/or one or more sensors… the sensors may measure one or more parameters and/or detect one or more elements related to, for example, diagnostic information, blood chemistry, pressure, flow rate, drug identification, microbes, placement of an implantable stent, in-vein catheter tip stabilization feature, or other device, etc….), the probe member having a distal end (Paragraph 0042, as sensors may be disposed near a distal tip of the probe) and a proximal end (end at which advancement tab 46 is coupled, Fig. 2A; Paragraph 0060);
the vascular access system also including a housing configured to movably receive at least a portion of the sensing probe assembly within an inner volume thereof (housing 28, Fig. 2A and 2D);
a lock configured to couple the housing to the near patient access port (Coupling mechanism 30; paragraph 0048-0049); and
an advancement member (advancement tab 46, Fig. 2A) configured to move relative to the housing to move the sensing probe assembly between a first position, in which a distal end of the probe member is disposed within the housing or the lock (Fig. 2A), and a second position in which a distal end of the probe member is disposed beyond the distal end portion of the housing and the lock and into the catheter or out past a distal tip of the catheter (Fig. 2D);
with the sensing probe assembly in the second position, the probe member is positioned to measure the one or more blood-related parameters (Paragraph 0042);
coupling the sensor probe delivery device to the near-patient access port of the catheter assembly (Paragraph 0048-0049, 0068-- couple the extension 10 with the catheter assembly 14…);
advancing the sensor probe assembly from the first position to the second position such that the distal end of the probe member extends into the catheter or beyond the distal end of the catheter (See Figs. 2A-2D; paragraph 0060, 0068-- the instrument 12 may then be advanced through the fluid pathway of the catheter assembly 14…).
Burkholz generally teaches that the probe member may connect to an electrical connector (Paragraph 0017, 0057, 0066).
However, Burkholz fails to explicitly disclose an electrical connector positioned proximally from the probe member, the electrical connector configured to operably connect to an external device and connecting an external device to the electrical connector of the sensor probe assembly, the external device comprising one of a wireless module and a data cable.
Willybiro in the same field of endeavor of intravenous devices having a plurality of sensors to provide measurements of patient parameters (Paragraph 0004), teaches a device having an electrical connector ( printed circuit board (PCB) 110 and means of coupling the PCB to the sensors 112, Fig. 1; Paragraph 0019-0028, 0031-- sensors 112 may be communicatively coupled to the PCB 110, physically coupled to the PCB 110, or both communicatively and physically coupled to the PCB 110) positioned proximally from a probe member (PCB 110 is positioned proximally from sensor 112 which demonstrates the position of the probe member, Fig. 1; Paragraphs 0018-0020), the electrical connector configured to operably connect to an external device (Paragraph 0028-0031) and connecting an external device to the electrical connector of the sensor probe assembly, the external device comprising one of a wireless module and a data cable (Paragraph 0028, 0051-0052, 0054-0056-- In the embodiment where the processor is placed remote of the intravenous device 100, the processor may be included within a computing device communicatively coupled to the sensors of the PCB 110 via a network interface device formed on the intravenous device 100… The data provided by the pressure sensor, temperature sensor, optical sensor, and accelerometer may be used individually or in combination by the processor of the computing device in order to generate conclusions… A network interface device 342 of the intravenous device may communicate data from the sensors 334, 336, 338, 340 over the network 328 using a network interface device 320 of the computing device, and to a processor that executes or operates the IV device control module 332 as described herein… video display 310 of the computing device may be used by a clinician to track the condition of the patient, detect changes in the condition of the patient which may indicate deterioration, and ultimately send out alarms to the clinician or other HCP; Paragraph 0028, 0031 0051-0052, 0054-0057-- electrical lines 120 may be used to communicatively couple the PCB 110 and its associated sensors and network interface device with, for example, a computing device, a power source, or both …).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vascular access system of Burkholz to further include an electrical connector positioned proximally from the probe member, the electrical connector configured to operably connect to an external device, as taught by Willybiro, in order to predictably improve the device by allowing for continuous real-time patient monitoring, which would improve the ability of a medical provider to provide prompt care to a patient having an adverse reaction to a medication or otherwise in need of treatment (Willybiro, Paragraph 0005). Furthermore, this may be seen as motivated by Burkholz’s disclosure of the device being connected to an electrical connector or other instrument (Paragraph 0017, 0057, 0066) such that Burkholz demonstrates that such a modification would have been obvious at the time of filing.
However, the combination of Burkholz and Willybiro fails to disclose the housing comprising a detachable portion separable from a remainder of the housing and disconnecting the detachable portion of the housing.
Devgon, in the same field of endeavor of fluid transfer medical devices (Paragraph 0002), teaches a device having a housing (introducer 210, Fig. 3) comprising a detachable portion separable from a remainder of the housing and disconnecting the detachable portion of the housing (Paragraph 0066--as first member 220 and second member 230 may be coupled via a mechanical fastener, one or more tabs, snaps, pins, and/or the like).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vascular access system of Burkholz to further include the housing comprising a detachable portion separable from a remainder of the housing, as taught by Devgon, in order to predictably improve the device by reducing undesirable variations in the shape and/or size of the inner surfaces of the housing, which in some instances, can reduce a likelihood of kinks, bends, and/or deformations of the corresponding catheter, as well as can allow an inner surface of the housing to form a tortuous shape that would otherwise present challenges when manufacturing the housing from a single workpiece (Devgon, Paragraph 0066).
Regarding Claim 15, the combination of Burkholz, Willybiro, and Devgon discloses the method of claim 14. However, Burkholz fails to explicitly disclose securing the wireless module in place via one or more of a stabilizing platform and a securement dressing.
Willybiro teaches securing the wireless module in place via one or more of a stabilizing platform and a securement dressing (Paragraph 0028-0029-- a stabilization patch used to secure the intravenous device 100 to the patient's body when the intravenous device 100 has interfaced with the patient's blood vessel. In this embodiment, the stabilization patch may also include a network interface device that communicatively couples the processor to a computing device, the PCB 110 of the intravenous device 100, or both).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vascular access system of Burkholz to further include an electrical connector positioned proximally from the probe member, the electrical connector configured to operably connect to an external device, as taught by Willybiro, in order to predictably improve the device by allowing for continuous real-time patient monitoring, which would improve the ability of a medical provider to provide prompt care to a patient having an adverse reaction to a medication or otherwise in need of treatment (Willybiro, Paragraph 0005). Furthermore, this may be seen as motivated by Burkholz’s disclosure of the device being connected to an electrical connector or other instrument (Paragraph 0017, 0057, 0066) such that Burkholz demonstrates that such a modification would have been obvious at the time of filing.
Regarding Claim 16, Burkholz discloses a sensor probe delivery device (extension 10, Fig. 1A; Paragraph 0042) coupleable to the near-patient access port to enable access to the catheter via the catheter assembly (Figures 1A-1B; Paragraphs 0040-0041), the delivery device comprising:
a sensing probe assembly (Fig. 1A) comprising: a probe member (instrument 12, Fig. 1A; Paragraph 0042) including one or more sensors configured to measure one or more blood-related parameters (Paragraph 0042-- the probe may include one or more openings and/or one or more sensors… the sensors may measure one or more parameters and/or detect one or more elements related to, for example, diagnostic information, blood chemistry, pressure, flow rate, drug identification, microbes, placement of an implantable stent, in-vein catheter tip stabilization feature, or other device, etc….), the probe member having a distal end (Paragraph 0042, as sensors may be disposed near a distal tip of the probe) and a proximal end (end at which advancement tab 46 is coupled, Fig. 2A; Paragraph 0060);
a housing configured to movably receive at least a portion of the sensing probe assembly within an inner volume thereof (housing 28, Fig. 2A and 2D);
a lock configured to couple the housing to the near patient access port (Coupling mechanism 30; paragraph 0048-0049); and
an advancement member (advancement tab 46, Fig. 2A) configured to move relative to the housing to move the sensing probe assembly between a first position, in which a distal end of the probe member is disposed within the housing or the lock (Fig. 2A), and a second position in which a distal end of the probe member is disposed beyond the distal end portion of the housing and the lock and into the catheter or out past a distal tip of the catheter (Fig. 2D);
wherein, with the sensing probe assembly in the second position, the probe member is positioned to measure the one or more blood-related parameters (Paragraph 0042).
Burkholz generally teaches that the probe member may connect to an electrical connector (Paragraph 0017, 0057, 0066).
However, Burkholz fails to explicitly disclose an electrical connector positioned proximally from the probe member, the electrical connector configured to operably connect to an external device.
Willybiro in the same field of endeavor of intravenous devices having a plurality of sensors to provide measurements of patient parameters (Paragraph 0004), teaches a device having an electrical connector ( printed circuit board (PCB) 110 and means of coupling the PCB to the sensors 112, Fig. 1; Paragraph 0019-0028, 0031-- sensors 112 may be communicatively coupled to the PCB 110, physically coupled to the PCB 110, or both communicatively and physically coupled to the PCB 110) positioned proximally from a probe member (PCB 110 is positioned proximally from sensor 112 which demonstrates the position of the probe member, Fig. 1; Paragraphs 0018-0020), the electrical connector configured to operably connect to an external device (Paragraph 0028-0031).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vascular access system of Burkholz to further include an electrical connector positioned proximally from the probe member, the electrical connector configured to operably connect to an external device, as taught by Willybiro, in order to predictably improve the device by allowing for continuous real-time patient monitoring, which would improve the ability of a medical provider to provide prompt care to a patient having an adverse reaction to a medication or otherwise in need of treatment (Willybiro, Paragraph 0005). Furthermore, this may be seen as motivated by Burkholz’s disclosure of the device being connected to an electrical connector or other instrument (Paragraph 0017, 0057, 0066) such that Burkholz demonstrates that such a modification would have been obvious at the time of filing.
However, the combination of Burkholz and Willybiro fails to disclose the housing comprising a detachable portion separable from a remainder of the housing.
Devgon, in the same field of endeavor of fluid transfer medical devices (Paragraph 0002), teaches a device having a housing (introducer 210, Fig. 3) comprising a detachable portion separable from a remainder of the housing (Paragraph 0066, as first member 220 and second member 230 may be coupled via a mechanical fastener, one or more tabs, snaps, pins, and/or the like).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vascular access system of Burkholz to further include the housing comprising a detachable portion separable from a remainder of the housing, as taught by Devgon, in order to predictably improve the device by reducing undesirable variations in the shape and/or size of the inner surfaces of the housing, which in some instances, can reduce a likelihood of kinks, bends, and/or deformations of the corresponding catheter, as well as can allow an inner surface of the housing to form a tortuous shape that would otherwise present challenges when manufacturing the housing from a single workpiece (Devgon, Paragraph 0066).
Regarding Claim 17, the combination of Burkholz, Willybiro, and Devgon discloses the sensor probe delivery device of claim 16. Burkholz additionally teaches wherein the housing comprises a coupler provided at a distal end portion thereof (sleeve 55, Figures 1, 3, 2H-2I), the coupler configured to mate with the lock (Coupling mechanism 30; paragraph 0064-0065) or formed integrally with a portion of the lock (Coupling mechanism 30; paragraph 0064-0065).
However, Burkholz fails to explicitly disclose that the detachable portion of the housing is configured to disconnect from the coupler.
Devgon teaches that the detachable portion of the housing is configured to disconnect from a coupler (coupler 216, Figures 4, 5, and 11; Paragraphs 0066 and 0069, as either of first member 220 and second member 230 is coupled to the remaining of the two via mechanical fasteners, tabs, snaps, pins, and/or the like, yielding it detachable from the remaining member, and therefore, the portion of it that forms coupler 216).
It would have been obvious to one of ordinary skill in the art before the priority date to modify the sensor probe delivery device of Burkholz to further include that the detachable portion of the housing is configured to disconnect from the coupler, as taught by Devgon, in order to predictably improve the device by reducing undesirable variations in the shape and/or size of the inner surfaces of the housing, which in some instances, can reduce a likelihood of kinks, bends, and/or deformations of the corresponding catheter, as well as can allow an inner surface of the housing to form a tortuous shape that would otherwise present challenges when manufacturing the housing from a single workpiece (Devgon, Paragraph 0066).
Regarding Claim 18, the combination of Burkholz, Willybiro, and Devgon discloses the sensor probe delivery device of claim 17. Burkholz generally teaches the sensing probe assembly may comprise a connector portion, wherein the connector portion is positioned adjacent the coupler when the sensing probe assembly is in the second position (Paragraph 0057, 0066—may include a luer fitting 40; see movement of the Luer fitting 40 in figs. 2A-2D). However, Burkholz fails to explicitly disclose that the sensing probe assembly comprises a connector portion including: a fitting configured to secure the proximal end of the probe member therein; and a flange member joined with the fitting; wherein the connector portion is positioned adjacent the coupler when the sensing probe assembly is in the second position, with the connector portion retained in the coupler.
Devgon teaches a probe assembly (Fig. 5) that comprises a connector portion (portion including actuator 270 that connects to proximal end portion 261 of catheter 260, Fig. 5) including: a fitting configured to secure the proximal end of the probe member therein (second portion 275 of actuator 270, Fig. 5); and a flange member joined with the fitting (wall 277, Fig. 17); wherein the connector portion is positioned adjacent the coupler when the probe assembly is in a second position, with the connector portion retained in the coupler (coupler 216, Fig. 28-29).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sensor probe delivery device of Burkholz to further include that the sensing probe assembly comprises a connector portion including: a fitting configured to secure the proximal end of the probe member therein; and a flange member joined with the fitting; wherein the connector portion is positioned adjacent the coupler when the sensing probe assembly is in the second position, with the connector portion retained in the coupler, as taught by Devgon, as a matter of simple substitution of parts known in the art, in this case the substitution of the luer fitting of Burkholz for the fitting and flange connection of Devgon.
Regarding Claim 19, the combination of Burkholz, Willybiro, and Devgon discloses the sensor probe delivery device of claim 18. Burkholz generally teaches that movement of the advancement member relative to the housing causes a corresponding movement of the sensing probe assembly (See Figs. 2A-2D). However, Burkholz fails to explicitly disclose that the advancement member is coupled with the flange of the connector portion, such that movement of the advancement member relative to the housing causes a corresponding movement of the sensing probe assembly.
Devgon teaches an advancement member coupled with the flange of the connector portion (engagement member 272, Fig. 17), such that movement of the advancement member relative to the housing causes a corresponding movement of the probe assembly (Figures 22 and 25).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sensor probe delivery device of Burkholz to further include that the advancement member is coupled with the flange of the connector portion, such that movement of the advancement member relative to the housing causes a corresponding movement of the sensing probe assembly, as taught by Devgon, as a matter of simple substitution of parts known in the art, in this case the substitution of the luer fitting of Burkholz for the fitting and flange connection of Devgon and additionally because Burkholz notes that the advancement tab may be disposed in any number of locations, including in alignment with the slot of the housing, to facilitate easy movement of the corresponding instrument (Burkholz, Paragraph 0060; Devgon, Figures 5 and 28).
Regarding Claim 20, the combination of Burkholz, Willybiro, and Devgon discloses the sensor probe delivery device of claim 19. Burkholz teaches the positioning of the connector portion (see luer fitting 40). However, Burkholz fails to explicitly disclose wherein the electrical connector is positioned within the housing when the sensing probe assembly is in each of the first position and the second position, with the electrical connector being accessible when the sensing probe assembly is in the second, upon disconnecting of the detachable portion.
Willybiro teaches the electrical connector is positioned within the housing when the sensing probe assembly is in each of the first position and the second position (Paragraph 0019-0020 where it is noted that a physical connection between the PCB and the sensors would extend through a housing), with the electrical connector being accessible when the sensing probe assembly is in the second, upon disconnecting of the detachable portion (Fig. 1A, the PCB 110 of the electrical connector would be accessible in any position of the sensing probe assembly).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the v sensor probe delivery device of Burkholz to further include wherein the electrical connector is positioned within the housing when the sensing probe assembly is in each of the first position and the second position, with the electrical connector being accessible when the sensing probe assembly is in the second, upon disconnecting of the detachable portion, as taught by Willybiro, in order to predictably improve the device by allowing for continuous real-time patient monitoring, which would improve the ability of a medical provider to provide prompt care to a patient having an adverse reaction to a medication or otherwise in need of treatment (Willybiro, Paragraph 0005). Furthermore, this may be seen as motivated by Burkholz’s disclosure of the device being connected to an electrical connector or other instrument at a proximal end of a connector (Paragraph 0017, 0057, 0066) such that Burkholz demonstrates that such a modification would have been obvious at the time of filing.
Conclusion
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/ANNA ROBERTS/Examiner, Art Unit 3791
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