DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 04/24/2024. Claims 1-20 are pending and examined below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 16, and claims dependent thereof, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 16, the claim recites the limitation “the adapter member having a distal end including a stopper insertable into the proximal end of the syringe and slidable within the barrel”. However, “the barrel” lacks antecedent basis. As such the claim is indefinite as it is unclear as to whether the claim is introducing a new limitation or referring to another limitation.
For the purpose of this examination “the barrel” is interpreted as “a barrel”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-7, 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20140309551 A1 (cited in IDS; hereinafter referred to as “Burkholz”) in view of WO 2005076733 A2 (cited in IDS, hereinafter referred to as “Carmi”) and US 20190308006 A1 (cited in IDS; hereinafter referred to as “Erekovanski”).
Regarding claim 1, Brukholz teaches a blood collection system, comprising a syringe assembly (collectively considered the vascular access device 12, 14, 16 and blood sampling device 110, Fig. 1, para. [0033]) comprising a syringe (needle 14 and blood sampling device 110, Fig. 1) having a distal end and a proximal end, the syringe defining a chamber (reservoir 118, Fig. 4, para. [0038]) and a fluid connector component (luer access adapter 22 of the blood sampling device 110 at the distal end of the needle, Fig. 1, para. [0035]) at the distal end; a plunger assembly including an adapter member, a receiving cavity, and a fluid access component, the adapter member having a distal end, the adapter member including a channel extending along a length thereof an opening of the receiving cavity, with the fluid access component positioned over the opening and extending into the receiving cavity (collection device 112 (plunger assembly) including cylindrical body 140 (adapter member) defining a interior region 146 (receiving cavity), the needle cannula 152 and tip 154 (collectively considered the fluid access component) extending into the filling adapter 150 (channel) in the interior region, Fig. 1, para. [0033, 0047, 0048]); a container defining a reservoir, the container positionable within the receiving cavity and engageable with the fluid access component to transfer fluid into the reservoir (the sample container 138 (container) is positionable in the interior region 146 having an open end 148 which receives the sample container 138 to be filled with a blood sample into a reservoir (considered the inner cavity that holds the blood sample) when the container closure 139 is pieced by needle tip 154, Figs. 5-7, paras. [0046, 0047]); but
Burkholz does not explicitly teach the adapter member having a distal end including a stopper insertable into the proximal end of the syringe and slidable within the barrel, a cannula having a distal end and a proximal end, the distal end of the cannula secured within the fluid connector component, with the cannula extending proximally through the stopper to place the fluid connector component in fluid communication with the channel and the fluid access component and a scrubbing cap secured to the fluid connector component of the syringe, the scrubbing cap comprising a housing secured to the fluid connector component and defining a cavity; and a scrubbing insert positioned within the cavity.
However, Carmi teaches the adapter member having a stopper insertable into the syringe and slidable within the barrel (plunger 50 (the adapter member) including a plunger cap 62 (a stopper) insertable into the barrel 52 of the syringe and slidable within the barrel 52, Figs. 2 and 3, page 9, 3rd paragraph- page 10), a cannula (needle 56, Fig. 2) having a distal end and a proximal end, the distal end of the cannula secured within the fluid connector component (the needle being secured in communication with the fluid connector component), with the cannula extending proximally through the stopper to place the fluid connector component in fluid communication with the channel and the fluid access component (the distal end of the 56 (cannula) secured within the plunger cap 62 (stopper) to place the forward end of the 66 and 72 (fluid connector component) in fluid communication with the 58 (channel), Figs. 2 and 3). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Burkholz to include the adapter member having a distal end including a stopper insertable into the proximal end of the syringe and slidable within the barrel, a cannula having a distal end and a proximal end, the distal end of the cannula secured within the fluid connector component, with the cannula extending proximally through the stopper to place the fluid connector component in fluid communication with the channel and the fluid access component, as taught by Carmi because doing so allows the user to monitor and control of the blood flow in order to prevent hemolysis.
Additionally, Erekovanski teaches a scrubbing cap (device 100 including an outer cap 102 and an inner cap 132, para. [0118]) secured to the fluid connector component, the scrubbing cap comprising a housing secured to the fluid connector component (the outer cap 102 (housing) includes the inner cap 132 has one or more threads 148 adapted to engage a male luer connector (fluid connector component), Fig. 4, para. [0118]) and defining a cavity and a scrubbing insert positioned within the cavity (closed end 106 defining the chamber (cavity) that contains the absorbent material (scrubbing insert), Fig. 4, para. [0118]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Burkholz, in view of Cami, to include a scrubbing cap secured to the fluid connector component of the syringe, the scrubbing cap comprising a housing secured to the fluid connector component and defining a cavity; and a scrubbing insert positioned within the cavity, as taught by Erekovanski because doing so streamlines the disinfecting process and decrease catheter-related bloodstream infections.
Regarding claim 2, Burkholz, in view of Carmi and Erekovanski, teaches the system of claim 1.
Burkholz does not explicitly teach wherein the scrubbing insert comprises a resilient material including an antimicrobial solution or agent absorbed therein configured to disinfect a surface of the access port of the vascular access device.
However, Erekovanski teaches wherein the scrubbing insert comprises a resilient material including an antimicrobial solution or agent absorbed therein configured to disinfect a surface of the access port of the vascular access device (the peelable seal 150 may be placed on the end face to prevent the disinfectant or the antimicrobial agent from exiting the chamber 112, para. [0118]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Burkholz, to include wherein the scrubbing insert comprises a resilient material including an antimicrobial solution or agent absorbed therein configured to disinfect a surface of the access port of the vascular access device, as taught by Burkholz because doing so allows for streamline the disinfecting process and decrease catheter-related bloodstream infections.
Regarding claim 3, Burkholz, in view of Carmi and Erekovanski, teaches the system of claim 2.
Burkholz does not explicitly teach wherein the scrubbing cap comprises a seal attached over the cavity to seal the scrubbing insert within the cavity.
However, Erekovanski teaches wherein the scrubbing cap comprises a seal attached over the cavity to seal the scrubbing insert within the cavity (the peelable seal 150 may be placed on the end face to prevent the disinfectant or the antimicrobial agent from exiting the chamber 112, para. [0118]). It would have been obvious to one of ordinary skill in the art before the relevant date to include wherein the scrubbing cap comprises a seal attached over the cavity to seal the scrubbing insert within the cavity based on the teachings of Burkholz to streamline the disinfecting process and decrease catheter-related bloodstream infections.
Regarding claim 4, Burkholz, in view of Carmi and Erekovanski, teaches the system of any of claim 1. Burkholz further teaches wherein the fluid connector component comprises a luer connector configured to be coupled to an access port or needleless connector of a vascular access device (a luer adapter port may be used to entirely enclose the luer access adapter 22 (fluid connector component) between the sampling device 110 and an access port of the vascular access device 12, para. [0034]); but Burkholz does not explicitly teach wherein the housing comprises a connector portion configured to engage with the luer connector to secure the scrubbing cap to the syringe assembly.
However, Erekovanski teaches wherein the housing comprises a connector portion configured to engage with the luer connector to secure the scrubbing cap lo the syringe assembly (the cap is removed from its packaging such as removing the seal, to connect the cap to the proximal end of a luer connector, the user applies an axial load such that the luer connector is engaged to the one or more threads of the exterior wall surface (connector portion) of the second end of the inner cap and rotated in a clockwise direction to secure the cap to the connector, para. [0010]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Burkholz to include wherein the housing comprises a connector portion configured to engage with the luer connector to secure the scrubbing cap to the syringe assembly based on the teachings of Erekovanski to streamline the disinfecting process and decrease catheter-related bloodstream infections.
Regarding claim 5, Burkholz, in view of Carmi and Erekovanski, teaches the system of claim 4. Burkholz does not explicitly teach wherein the luer connector comprises one of a slip luer, a threaded luer, or a luer lock with collar.
However, Erekovanski teaches wherein the luer connector comprises one of a slip luer, a threaded luer, or a luer lock with collar (the cap is removed from its packaging such as removing the seal, to connect the cap to the proximal end of a threaded luer connector, the user applies an axial load such that the luer connector is engaged to the one or more threads of the exterior wall surface (connector portion) of the second end of the inner cap and rotated in a clockwise direction to secure the cap to the connector, para. [0010]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Burkholz to include wherein the luer connector comprises one of a slip luer, a threaded luer, or a luer lock with collar based on the teachings of Erekovanski to streamline the disinfecting process and decrease catheter-related bloodstream infections.
Regarding claim 6, Burkholz, in view of Carmi and Erekovanski, teaches the system of claim 1. Burkholz does not explicitly teach wherein the housing comprises a connector portion configured to secure the scrubbing cap to the fluid connector component via a twist-type engagement, and wherein the scrubbing cap is removable to enable connection of the syringe assembly to the access port or needleless connector of the vascular access device.
However, Erekovanski teaches wherein the housing comprises a connector portion configured to secure the scrubbing cap to the fluid connector component via a twist-type engagement, and wherein the scrubbing cap is removable to enable connection of the syringe assembly to the access port or needleless connector of the vascular access device (the cap is removed from its packaging such as removing the seal, to connect the cap to the proximal end of a luer connector (an access port), the user applies an axial load such that the luer connector is engaged to the one or more threads of the exterior wall surface (connector portion) of the second end of the inner cap and rotated in a clockwise direction to secure the cap to the connector, para. [0010]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Burkholz to include wherein the housing comprises a connector portion configured to secure the scrubbing cap to the fluid connector component via a twist-type engagement, and wherein the scrubbing cap is removable to enable connection of the syringe assembly to the access port or needle less connector of the vascular access device based on the teaching of Erekovanski to improve the ease of compliance to cleaning protocol and decrease catheter-related bloodstream infections.
Regarding claim 7, Burkholz, in view of Carmi and Erekovanski, teaches the system of claim 1. Burkholz further teaches wherein the fluid access component comprises a needle defining a lumen therein (the needle cannula 152 and tip 154 (collectively considered the fluid access component) extending into the filling adapter 150 (channel) in the interior region, such that the needle cannula defines a lumen 126 through which the blood sample flows into the container reservoir, Fig. 7, para. [0033, 0047, 0048]), and wherein the container comprises a cover pierceable by the needle to place the reservoir in fluid communication with the channel of the plunger assembly (the sample container 138 (container) is positionable in the interior region 146 having an open end 148 which receives the sample container 138 to be filled with a blood sample into a reservoir (considered the inner cavity that holds the blood sample) when the container closure 139 is pieced by needle tip 154, Figs. 5-7, paras. [0046, 0047]).
Regarding claim 11, Burkholz teaches a syringe assembly (collectively considered the vascular access device 12, 14, 16 and blood sampling device 11 o, Fig. 1, para. [0033]) comprising a syringe (needle 14 and blood sampling device 110, Fig. 1) having a distal end and a proximal end, the syringe defining a chamber (reservoir 118, Fig. 4, para. [0038]) and a fluid connector component (luer access adapter 22 of the blood sampling device 110 at the distal end of the needle, Fig. 1, para. [0035]) at the distal end; a plunger assembly including an adapter member, a receiving cavity, and a fluid access component, the adapter member including a channel extending along a length thereof an opening of the receiving cavity, with the fluid access component positioned over the opening and extending into the receiving cavity (collection device 112 (plunger assembly) including cylindrical body 140 (adapter member) defining an interior region 146 (receiving cavity), the needle cannula 152 and tip 154 (collectively considered the fluid access component) extending into the filling adapter 150 (channel) in the interior region, Fig. 1, para. [0033, 0047, 0048]). Burkholz does not explicitly teach the adapter member having a distal end including a stopper insertable into the proximal end of the syringe and slidable within the barrel, a cannula having a distal end and a proximal end, the distal end of the cannula secured within the fluid connector component, with the cannula extending proximally through the stopper and into the channel to place the fluid connector component in fluid communication with the fluid access component; and a scrubbing cap secured to the fluid connector component of the syringe, the scrubbing cap comprising a housing secured to the fluid connector component and defining a cavity; and a scrubbing insert positioned within the cavity.
However, Carmi teaches the adapter member having a stopper insertable into the syringe and slidable within the barrel (plunger 50 (the adapter member) including a plunger cap 62 (a stopper) insertable into the barrel 52 of the syringe and slidable within the barrel 52, Figs. 2 and 3, page 9, 3rd paragraph- page 10), a cannula (needle 56, Fig. 2) having a distal end and a proximal end, the distal end of the cannula secured within the fluid connector component (the needle being secured in communication with the fluid connector component), with the cannula extending proximally through the stopper to place the fluid connector component in fluid communication with the channel and the fluid access component (the distal end of the 56 (cannula) secured within the plunger cap 62 (stopper) to place the forward end of the 66 and 72 (fluid connector component) in fluid communication with the 58 (channel), Figs. 2 and 3). It would have been obvious to one of ordinary skill in the art before the relevant date to include the adapter member having a distal end including a stopper insertable into the proximal end of the syringe and slidable within the barrel, a cannula having a distal end and a proximal end, the distal end of the cannula secured within the fluid connector component, with the cannula extending proximally through the stopper to place the fluid connector component in fluid communication with the channel and the fluid access component based on the teaching of Carmi to allow the user to monitor and control of the blood flow in order to prevent hemolysis.
Additionally, Erekovanski teaches a scrubbing cap (device 100 including an outer cap 102 and an inner cap 132, para. [0118]) secured to the fluid connector component, the scrubbing cap comprising a housing secured to the fluid connector component (the outer cap 102 (housing) includes the inner cap 132 has one or more threads 148 adapted to engage a male luer connector (fluid connector component), Fig. 4, para. [0118]) and defining a cavity and a scrubbing insert positioned within the cavity (closed end 106 defining the chamber (cavity) that contains the absorbent material (scrubbing insert), Fig. 4, para. [0118]). It would have been obvious to one of ordinary skill in the art before the relevant date to include a scrubbing cap secured to the fluid connector component of the syringe, the scrubbing cap comprising a housing secured to the fluid connector component and defining a cavity; and a scrubbing insert positioned within the cavity based on the teachings of Burkholz to streamline the disinfecting process and decrease catheter-related bloodstream infections.
Regarding claim 12, Burkholz, in view of Carmi and Erekovanski, teaches the syringe assembly of claim 11. Burkholz does not explicitly teach wherein the scrubbing insert comprises a resilient material including an antimicrobial solution or agent absorbed therein.
However, Erekovanski teaches wherein the scrubbing insert comprises a resilient material including an antimicrobial solution or agent absorbed therein (the peelable seal 150 may be placed on the end face to prevent the disinfectant or the antimicrobial agent from exiting the chamber 112, para. [0118]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Burkholz to include wherein the scrubbing insert comprises a resilient material including an antimicrobial solution or agent absorbed therein based on the teachings of Burkholz to streamline the disinfecting process and decrease catheter-related bloodstream infections.
Regarding claim 13, Burkholz, in view of Carmi and Erekovanski, teaches the syringe assembly of claim 11. Burkholz does not explicitly teach wherein the scrubbing cap comprises a seal attached over the cavity to seal the scrubbing insert within the cavity. However, Erekovanski teaches wherein the scrubbing cap comprises a seal attached over the cavity to seal the scrubbing insert within the cavity (the peelable seal 150 may be placed on the end face to prevent the disinfectant or the antimicrobial agent from exiting the chamber 112, para. [0118]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Burkholz to include wherein the scrubbing cap comprises a seal attached over the cavity to seal the scrubbing insert within the cavity based on the teachings of Burkholz to streamline the disinfecting process and decrease catheter-related bloodstream infections.
Regarding claim 14, Burkholz, in view of Carmi and Erekovanski, teaches the syringe assembly of claim 11. Burkholz further teaches wherein the fluid connector component comprises a luer connector configured to be coupled to the access port or needleless connector of a vascular access device (a luer adapter port may be used to entirely enclose the luer access adapter 22 between the sampling device 110 and an access port of the vascular access device 12, para. [0034]). Burkholz does not explicitly teach wherein the housing comprises a connector portion configured to engage with the luer connector to secure the scrubbing cap to the syringe assembly.
However, Erekovanski teaches wherein the housing comprises a connector portion configured to engage with the luer connector to secure the scrubbing cap to the syringe assembly (the cap is removed from its packaging such as removing the seal, to connect the cap to the proximal end of a luer connector (an access port), the user applies an axial load such that the luer connector is engaged to the one or more threads of the exterior wall surface (connector portion) of the second end of the inner cap and rotated in a clockwise direction to secure the cap to the connector, para. [001 OJ). It would have been obvious to one of ordinary skill in the art before the relevant date to include the method comprising wherein the housing comprises a connector portion configured to engage with the luer connector to secure the scrubbing cap to the syringe assembly based on the teaching of Burkholz to improve the ease of compliance to cleaning protocol and decrease catheter-related bloodstream infections.
Regarding claim 15, Burkholz, in view of Carmi and Erekovanski, teaches the syringe assembly of claim 14. Burkholz does not explicitly teach wherein the connector portion of the housing secures the scrubbing cap via a twist-type engagement, and wherein the scrubbing cap is removable to enable connection of the syringe assembly to the access port or needleless connector of the vascular access device.
However, Erekovanski teaches wherein the connector portion of the housing secures the scrubbing cap via a twist-type engagement, and wherein the scrubbing cap is removable to enable connection of the syringe assembly to the access port or needleless connector of the vascular access device (the cap is removed from its packaging such as removing the seal, to connect the cap to the proximal end of a luer connector (an access port), the user applies an axial load such that the luer connector is engaged to the one or more threads of the exterior wall surface (connector portion) of the second end of the inner cap and rotated in a clockwise direction to secure the cap to the connector, para. [001 OJ). It would have been obvious to one of ordinary skill in the art before the relevant date to include the method comprising wherein the connector portion of the housing secures the scrubbing cap via a twist-type engagement, and wherein the scrubbing cap is removable to enable connection of the syringe assembly to the access port or needleless connector of the vascular access device based on the teaching of Burkholz to improve the ease of compliance to cleaning protocol and decrease catheter-related bloodstream infections.
Regarding claim 16, Burkholz teaches a method of using a blood sample collection system (the sample container collection device 112 is configured to establish fluid communication between the separate vascular access device 12 and the sample container 138, para. [0046]) comprising providing a syringe assembly (collectively considered the vascular access device 12, 14, 16 and blood sampling device 110, Fig. 1, para. [0033]) including a syringe (needle 14 and blood sampling device 110, Fig. 1) having a distal end and a proximal end, the syringe defining a chamber (reservoir 118, Fig. 4, para. [0038]) and a fluid connector component (luer access adapter 22 of the blood sampling device 110 at the distal end of the needle, Fig. 1, para. [0035]) at the distal end; a plunger assembly including an adapter member, a receiving cavity, and a fluid access component, the adapter member including a channel extending along a length thereof and an opening of the receiving cavity, with the fluid access component positioned over the opening and extending into the receiving cavity (collection device 112 (plunger assembly) including cylindrical body 140 (adapter member) defining a interior region 146 (receiving cavity), the needle cannula 152 and lip 154 (collectively considered the fluid access component) extending into the filling adapter 150 (channel) in the interior region, Fig. 1, para. [0033, 0047, 0048]). Burkholz does not explicitly teach the adapter member having a distal end including a stopper insertable into the proximal end of the syringe and slidable within the barrel, a cannula having a distal end and a proximal end, the distal end of the cannula secured within the fluid connector component, with the cannula extending proximally through the stopper and into the channel to place the fluid connector component in fluid communication with the fluid access component; and a scrubbing cap secured to the fluid connector component of the syringe, the scrubbing cap comprising a housing secured to the fluid connector component and defining a cavity; and a scrubbing insert positioned within the cavity; positioning the scrubbing cap over an access port of a vascular access device, such that the proximal connector contacts the scrubbing insert; and cleaning the access port with the scrubbing insert.
However, Carmi teaches the adapter member having a stopper insertable into the syringe and slidable within the barrel (plunger 50 (the adapter member) including a plunger cap 62 (a stopper) insertable into the barrel 52 of the syringe and slidable within the barrel 52, Figs. 2 and 3, page 9, 3rd paragraph- page 10), a cannula (needle 56, Fig. 2) having a distal end and a proximal end, the distal end of the cannula secured within the fluid connector component (the needle being secured in communication with the fluid connector component), with the cannula extending proximally through the stopper to place the fluid connector component in fluid communication with the channel and the fluid access component (the distal end of the 56 (cannula) secured within the plunger cap 62 (stopper) to place the forward end of the 66 and 72 (fluid connector component) in fluid communication with the 58 (channel), Figs. 2 and 3). It would have been obvious to one of ordinary skill in the art before the relevant date to include the adapter member having a distal end including a stopper insertable into the proximal end of the syringe and slidable within the barrel, a cannula having a distal end and a proximal end, the distal end of the cannula secured within the fluid connector component, with the cannula extending proximally through the stopper to place the fluid connector component in fluid communication with the channel and the fluid access component based on the teaching of Carmi to allow the user to monitor and control of the blood flow in order to prevent hemolysis.
Additionally, Erekovanski teaches a scrubbing cap (device 100 including an outer cap 102 and an inner cap 132, para. [0118]) secured to the fluid connector component, the scrubbing cap comprising a housing secured to the fluid connector component (the outer cap 102 (housing) includes the inner cap 132 has one or more threads 148 adapted to engage a male luer connector (fluid connector component), Fig. 4, para. [0118]) and defining a cavity and a scrubbing insert positioned within the cavity (closed end 106 defining the chamber (cavity) that contains the absorbent material (scrubbing insert), Fig. 4, para. [0118]); positioning the scrubbing cap over an access port of a vascular access device, such that the proximal connector contacts the scrubbing insert; and cleaning the access port with the scrubbing insert (the device is removed from its packaging such as removing the seal, to connect the device to the proximal end of a luer connector (an access port), the user applies an axial load such that a luer connector is engaged to the one or more threads of the exterior wall surface of the second end of the inner cap and rotated in a clockwise direction, once the insert of the device is engaged to the connector, the device may be removed from the connector by rotating the device counter -clockwise, para. [001 O]). It would have been obvious to one of ordinary skill in the art before the relevant date to include a scrubbing cap secured to the fluid connector component of the syringe, the scrubbing cap comprising a housing secured to the fluid connector component and defining a cavity; and a scrubbing insert positioned within the cavity based on the teachings of Erekovanski to streamline the disinfecting process and decrease catheter-related bloodstream infections.
Regarding claim 17, Burkholz, in view of Carmi and Erekovanski, teaches the method of claim 16. Burkholz further teaches wherein the fluid connector component comprises a luer connector configured to be coupled to the access port (a luer adapter port may be used to entirely enclose the luer access adapter 22 between the sampling device 110 and an access port of the vascular access device 12, para. [0034]). Burkholz does not explicitly teach wherein the scrubbing cap comprises a connector portion engaged with the luer connector to secure the scrubbing cap to the syringe.
However, Erekovanski teaches wherein the scrubbing cap comprises a connector portion engaged with the luer connector to secure the scrubbing cap to the syringe (the cap is removed from its packaging such as removing the seal, to connect the cap to the proximal end of a luer connector (an access port), the user applies an axial load such that the luer connector is engaged to the one or more threads of the exterior wall surface (connector portion) of the second end of the inner cap and rotated in a clockwise direction to secure the cap to the connector, para. [0010]). It would have been obvious to one of ordinary skill in the art before the relevant date to include the method comprising wherein the scrubbing cap comprises a connector portion engaged with the luer connector to secure the scrubbing cap to the syringe based on the teaching of Burkholz to improve the ease of compliance to cleaning protocol and decrease catheter-related bloodstream infections.
Regarding claim 18, Burkholz, in view of Carmi and Erekovanski, teaches the method of claim 17. Burkholz further teaches coupling the luer connector to the access port, to place the syringe assembly in fluid connection with the vascular access device (a luer adapter port may be used to entirely enclose the luer access adapter 22 between the sampling device 11 O and vascular access device 12, para. [0034]). Burkholz does not explicitly teach detaching the scrubbing cap from the luer connector subsequent to cleaning of the access port.
However, Erekovanski teaches detaching the scrubbing cap from the luer connector subsequent to cleaning of the access port (once the device is engaged to the connector, the device may be removed from the connector by rotating the device counter-clockwise, and upon disengagement, the inner cap and the outer cap remain intact and attached to each other, para. [0010]). It would have been obvious to one of ordinary skill in the art before the relevant date to include the method comprising detaching the scrubbing cap from the lock subsequent to cleaning of the proximal connector based on the teaching of Burkholz to improve the ease of compliance to cleaning protocol and decrease catheter-related bloodstream infections.
Regarding claim 19, Burkholz, in view of Carmi and Erekovanski, teaches the method of claim 16. Burkholz does not explicitly teach wherein the scrubbing cap comprises a seal attached over the cavity to seal the scrubbing insert within the cavity, and wherein the method further comprises removing the seal from the scrubbing cap, lo enable positioning of the scrubbing cap over the access port of the vascular access device and contacting of the scrubbing insert with the access port.
However, Erekovanski teaches wherein the scrubbing cap comprises a seal attached over the cavity to seal the scrubbing insert within the cavity, and wherein the method further comprises removing the seal from the scrubbing cap, to enable positioning of the scrubbing cap over the access port of the vascular access device and contacting of the scrubbing insert with the access port (the device is removed from its packaging such as removing the seal, to connect the device lo the proximal end of a luer connector (an access port), the user applies an axial load such that a luer connector is engaged lo the one or more threads of the exterior wall surface of the second end of the inner cap and rotated in a clockwise direction, once the insert of the device is engaged to the connector, the device may be removed from the connector by rotating the device counter-clockwise, para. [0010]). It would have been obvious lo one of ordinary skill in the art before the relevant date to include wherein the scrubbing cap comprises a seal attached over the cavity lo seal the scrubbing insert within the cavity, and wherein the method further comprises removing the seal from the scrubbing cap, lo enable positioning of the scrubbing cap over the access port of the vascular access device and contacting of the scrubbing insert with the access port based on the teachings of Erekovanski to streamline the disinfecting process and decrease catheter-related bloodstream infections.
Regarding claim 20, Burkholz, in view of Carmi and Erekovanski, teaches the method of claim 16. Burkholz does not explicitly teach wherein cleaning the access port comprises applying a twisting motion to the blood sample collection system.
However, Erekovanski teaches wherein cleaning the access port comprises applying a twisting motion to the blood sample collection system (the device is removed from its packaging such as removing the seal, to connect the device to the proximal end of a luer connector (an access port), the user applies an axial load such that a luer connector is engaged to the one or more threads of the exterior wall surface of the second end of the inner cap and rotated in a clockwise direction, once the insert of the device is engaged to the connector, the device may be removed from the connector by rotating the device counter -clockwise, para. [0010]). It would have been obvious to one of ordinary skill in the art before the relevant date to include wherein cleaning the access port comprises applying a twisting motion to the blood sample collection system based on the teachings of Erekovanski to streamline the disinfecting process and decrease catheter-related bloodstream infections.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz, in view of Carmi and Erekovanski as applied to claim 1 above, and further in view of US 4,886,072 B2 (hereinafter referred to as “Percarpio”).
Regarding claim 8, Burkholz, in view of Carmi and Erekovanski, teaches the system of claim 1. Burkholz teaches a female luer connector and a male luer connector (the narrow tubular portion 120 may be a male luer lock connection 124 adapted for insertion into the female luer access adapter 22 of the vascular access device 12, [0038]), but does not explicitly teach wherein the fluid access component comprises a female luer connector, and wherein the container comprises a male luer connector engageable with the female luer connector to place the reservoir in fluid communication with the channel of the plunger assembly.
However, Percarpio teaches wherein the fluid access component comprises a female threaded connector, and wherein the container comprises a male threaded connector engageable with the female threaded connector to place the reservoir in fluid communication with the channel of the assembly (housing 12 includes a negative pressure hub portion 25 having threads 18 adjacent the second cannula 15 onto which a container holder 19 is threaded by its internal mating threads 20 at the forward end of the holder, col. 3, Ins. 60-65). It would have been obvious to one of ordinary skill in the art before the relevant date to include wherein the fluid access component comprises a female luer connector, and wherein the container comprises a male luer connector engageable with the female luer connector to place the reservoir in fluid communication with the channel of the plunger assembly based on the teachings of Percarpio in order to securely attach the components with suitable locking means.
Regarding claim 9, Burkholz, in view of Carmi and Erekovanski, teaches the system of claim 1. Burkholz does not explicitly teach wherein the fluid connector component comprises an opening formed therein and wherein the cannula is positioned within the opening, the cannula having a cross-section smaller than the opening.
However, Percarpio teaches wherein the fluid connector component comprises an opening formed therein and wherein the cannula is positioned within the opening, the cannula having a cross-section smaller than the opening (housing 12 includes a negative pressure hub portion 25 having threads 18 adjacent the second cannula 15 onto which a container holder 19 is threaded by its internal mating threads 20 at the forward end of the holder, the tubular configuration of the cannula being a smaller cross-section than the opening, Figs. 1 and 2, col. 3, Ins. 60-64). It would have been obvious to one of ordinary skill in the art before the relevant date lo include wherein the fluid connector component comprises an opening formed therein and wherein the cannula is positioned within the opening, the cannula having a cross-section smaller than the opening based on the teaching of Percarpio since such a modification would involve a mere change in the size of a component and a change in size is generally recognized as being within the level of ordinary skill in the art.
Regarding claim 10, Burkholz, in view of Carmi, Burkholz, '006 and Percarpio, teaches the system of claim 9. Burkholz does not explicitly teach wherein a gap between an outer diameter of the opening and the cannula forms a first fluid path from the fluid connector component into a fluid chamber defined by a distal end of the stopper and an inner surface of the distal end of the syringe, and wherein the cannula forms a second fluid path from the fluid connector component to the fluid access component. Percarpio teaches wherein a gap between an outer diameter of the opening and the cannula forms a first fluid path from the fluid connector component into a fluid chamber defined by a distal end of the stopper and an inner surface of the distal end of the syringe, and wherein the cannula forms a second fluid path from the fluid connector component to the fluid access component (housing 12 includes a negative pressure hub portion 25 having threads 18 adjacent the second cannula 15 onto which a container holder 19 is threaded by its internal mating threads 20 at the forward end of the holder, such that the cannula has a cross-section smaller that the cross section of the hub portion and thereby smaller than the container opening, Figs. 1 and 2, col. 3, Ins. 60-64). It would have been obvious to one of ordinary skill in the art before the relevant date to include wherein a gap between an outer diameter of the opening and the cannula forms a first fluid path from the fluid connector component into a fluid chamber defined by a distal end of the stopper and an inner surface of the distal end of the syringe, and wherein the cannula forms a second fluid path from the fluid connector component to the fluid access component based on the teaching of Percarpio to provide a negative pressure in a first fluid path while the same may enter the container through the second fluid path, thereby providing controlled fluid flow.
Conclusion
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/ABID A MUSTANSIR/ Examiner, Art Unit 3791