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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
The claim limitation on page 2, line 16: “insets into the second slot” should “read inserts into the slot”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7, 9-12, and 21-29 are rejected under 35 U.S.C. 103 as being unpatentable over Abitabilo et al. (US 20170239443 A1) in view of Weber (US 20160287857 A1) in further view of Karthikeyan et al. (US 20190247642 A1).
Regarding claim 1, Abitabilo discloses a catheter system (catheter assembly 100, Fig 2A), comprising: a catheter adapter (catheter hub 110, Fig 3A) having a proximal end (7000, Annotated Fig 7), a distal end (7001, Annotated Fig 7), a side port (7002, Annotated Fig 7) and a lumen (lumen of catheter hub As seen in Fig 4B) that provides fluid communication between the proximal end (7000, Annotated Fig 7), the distal end (7001, Annotated Fig 7) and the side port (7002, Annotated Fig 7): a catheter (catheter tube 108, Fig 4A) that extends distally from the distal end (7001, Annotated Fig 7) of the catheter adapter (110); a needle hub (catheter insertion device 102, Fig 4B) coupled to the proximal end of the catheter adapter (110): an introducer needle (insertion needle 104, Fig 4A) that extends distally from the needle hub (102) such that the introducer needle (104) extends distally through the catheter (108): an extension tube (an extension tube 114, Fig 4A) that extends from the side port (7002, Annotated Fig 7): a female luer adapter (needleless connector 118 including luer connector 119, Fig 27A) comprising a proximal end (1001, Annotated Fig 1) and a distal end (1002, Annotated Fig 1) that is coupled to the extension tube (114); wherein the female luer adapter (118) is in fluid communication with the catheter (108) via the extension tube (114) and the lumen (lumen of hub 110); a cap (vent cap 120, Fig 28) that is configured to be secured to the female luer adapter (118, Fig 30A-B) to function as a vent plug for the female luer adapter (118) ([0172]), the cap (120) comprising: a top (1003, Annotated Fig 2); a male luer (nose 196, Fig 30B) extending distally from the top (1003, Annotated Fig 2) and inserted into the proximal end (1001, Annotated Fig 1) of the female luer adapter (118) to function as the vent plug ([0172]); a first arm (204_1, Annotated Fig 2) extending distally from the top (1003, Annotated Fig 2) along a longitudinal axis (L, Annotated Fig 2) of the cap (120) to define a length of the first arm (2000, Annotated Fig 2); a second arm (204_1, Annotated Fig 2) extending distally from the top (1003, Annotated Fig 2) along the longitudinal axis (L, Annotated Fig 2) of the cap (120) to define a length (2001, Annotated Fig 2) of the second arm (204_1, Annotated Fig 2), wherein a diameter (OD1, Annotated Fig 2) of the male luer (196) is configured to substantially match an inner diameter of the female luer adapter (118) when the male luer (196) has been inserted into the female luer adapter (118) to a third distance (fully insertion distance (FID), Fig 30B).
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Abitabilo is silent wherein the proximal end (1001, Annotated Fig 1) of the female luer adapter (118) comprises a first protrusion and a second protrusion that extend radially outwardly from a longitudinal axis of the female luer adapter to define a threading of the female luer that is configured to receive a male luer lock connector, wherein radial edges of the first and second protrusions are positioned at a first radial distance from the longitudinal axis of the female luer adapter, wherein the first comprises a first slot; wherein the second arm comprises a second slot; wherein each of the first and second slots are positioned at a second distance from the top along the longitudinal axis of the cap, the second distance being less than the lengths of the first and second arms; wherein each of the first and second slots are positioned at a second radial distance from the longitudinal axis of the cap, the second radial distance being less than the first radial distance; and wherein, wherein the male luer (196) is inserted to the third distance (FID), the first and second slots align with the first and second protrusions along a plane that is perpendicular to the longitudinal axes of the female luer adapter and the cap; wherein in response to rotation of the cap with respect to the female luer adapter in a first direction, the first protrusion inserts into the first slot until contacting an end of the first slot and the second protrusion insets into the second slot until contacting is an end of the second slot to prevent further rotation of the cap in the first direction and to prevent the cap from being removed from the female luer adapter due to the radial edges of the first and second protrusions being positioned at the first radial distance which is greater than the second radial distance at which the first and second slot are positioned, wherein in response to rotation of the cap with respect to the female luer adapter in a second direction opposite the first direction, the first protrusion is configured to be removed from the first slot and the second protrusion is configured to be removed from the second slot to thereby allow the cap to be removed from the female luer adapter by pulling the cap proximally relative to the female luer adapter.
Weber teaches a female luer adapter (base body 10, Fig 1; [0078]) wherein the proximal end (2001, Annotated Fig 3) of the female luer adapter (10) comprises a first protrusion (33_1, Annotated Fig 3) and a second protrusion (33_2, Annotated Fig 3) that extend radially outwardly from a longitudinal axis (2014, Annotated Fig 3) of the female luer adapter (10) that is configured to receive a male luer lock connector (50), wherein radial edges (Annotated Fig 3) of the first (33_1, Annotated Fig 3) and second protrusions (33_2, Annotated Fig 3) are positioned at a first radial distance (D1, Annotated Fig 3) from the longitudinal axis (2014, Annotated Fig 3) of the female luer adapter (10), wherein the first arm (2002, Annotated Fig 4) comprises a first slot (2004, Annotated Fig 4); wherein the second arm (2003, Annotated Fig 4) comprises a second slot (2005, Annotated Fig 4); wherein each of the first (2005, Annotated Fig 4) and second slots (2005, Annotated Fig 4) are positioned at a second distance (D2, Annotated Fig 3) from the top (3000, Annotated Fig 3) along the longitudinal axis of the cap (Longitudinal axis 2014, Annotated Fig 3), the second distance (D2, Annotated Fig 3) being less than the lengths of the first (L1, Annotated Fig 3)and second arms (L1, annotated Fig 3); wherein each of the first (2004, Annotated Fig 4) and second slots (2005, Annotated Fig 4) are positioned at a second radial distance (RD2, Annotated Fig 3) from the longitudinal axis (2014, Annotated Fig 3) of the cap (50), the second radial distance (RD2, Annotated Fig 3) being less than the first radial distance (RD1, Annotated Fig 3); and wherein, wherein the male luer is inserted to the third distance (insertion distance, Fig 8 shows the two parts after insertion), the first (2004, Annotated Fig 4) and second slots (2005, Annotated Fig 4) align with the first (33_1, Annotated Fig 3) and second protrusions (33_2, Annotated Fig 3) along a plane (plane show in Fig 8) that is perpendicular to the longitudinal axes (2014, Annotated Fig 3) of the female luer adapter (10) and the cap (50); wherein in response to rotation of the cap (50) with respect to the female luer adapter (10) in a first direction (clockwise), the first protrusion (33_1, Annotated Fig 3) inserts into the first slot (2004, Annotated Fig 4) until contacting an end (2006, Annotated Fig 4)of the first slot (end of slot as contacts the end of protrusion as seen in Fig 7) and the second protrusion (33_2, Annotated Fig 3) insets into the second slot (2005, Annotated Fig 4) until contacting is an end (2007, Annotated Fig 4) of the second slot (2005, Annotated Fig 4) to prevent further rotation of the cap (50) in the first direction (Clockwise) and to prevent the cap (50) from being removed from the female luer adapter (10) due to the radial edges of the first (2016_1, Annotated Fig 3) and second protrusions (2016_2, Annotated Fig 3) being positioned at the first radial distance (RD1, Annotated Fig 3) which is greater than the second radial distance (RD2, Annotated Fig 3) at which the first (2004, Annotated Fig 4) and second slot are positioned (2005, Annotated Fig 4), wherein in response to rotation of the cap (50) with respect to the female luer adapter (10) in a second direction (counterclockwise) opposite the first direction (clockwise), the first protrusion (33_1, Annotated Fig 3) is configured to be removed from the first slot (2004, Annotated Fig 4) and the second protrusion (33_2, Annotated Fig 3) is configured to be removed from the second slot (2005, Annotated Fig 4) to thereby allow the cap (50) to be removed from the female luer adapter (10) by pulling the cap (50) proximally relative to the female luer adapter (10).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo with similar locking mechanism of the arms of cap with the protrusion of the adapter as taught by Weber for the purpose of enhancing securing the components together and prevent unwanted disconnection ([0043]; [0119]: “A maximum security against disconnection on suddenly occurring tensile stresses is ensured by the principle of the bayonet connection”)
Abitabilo/Weber are silent wherein the first and the second protrusion define a threading of the female luer.
Karthikeyan teaches a catheter system (catheter system 10, Fig 1) comprising a female luer adapter (adapter 30, Fig 4A) wherein a first protrusion (3001, Annotated Fig 6) and the second protrusion (3002, Annotated Fig 6) define a threading (threads 32, Fig 2E; [0051]).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber with similar protrusions on a threading as taught by Karthikeyan for the purpose of having a threading protrusion to increase the surface and time of contact when the protrusion passes through the bump of the slots, to further secure the engaging components ([0053]).
Regarding claim 2, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 1. Abitabilo is silent wherein the first slot comprises a longitudinal edge opposite another longitudinal edge, wherein the longitudinal edge or the other longitudinal edge of the first slot comprises a first bump, wherein the first bump interferes with the first protrusion to resist rotation of the cap in the second direction.
Weber teaches wherein the first slot (2004, Annotated Fig 4) comprises a longitudinal edge (2008, Annotated Fig 4) opposite another longitudinal edge (2009, Annotated Fig 4), wherein the longitudinal edge (2008, Annotated Fig 4) or the other longitudinal edge of the first slot (2004, Annotated Fig 4) comprises a first bump (latch 44, Fig 4), wherein the first bump (44) interferes with the first protrusion (33_1, Annotated Fig 3) to resist rotation of the cap (50) in the second direction (counterclockwise) ([0023]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber/Karthikeyan with similar locking mechanism comprising ledges and bump as taught by Weber for the purpose of securing the components and provide an audible and haptic feedback when the contact parts reach the locking position ([0023]).
Regarding claim 3, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 2. Abitabilo is silent wherein the second slot comprises a longitudinal edge opposite another longitudinal edge, wherein the longitudinal edge or the other longitudinal edge of the second slot comprises a second bump, wherein the second bump interferes with the second protrusion to resist rotation of the cap in the second direction.
Weber wherein teaches the second slot (2005, Annotated Fig 4) comprises a longitudinal edge (2010, Annotated Fig 4) opposite another longitudinal edge (2011, Annotated Fig 4), wherein the longitudinal edge (2010, Annotated Fig 4) or the other longitudinal edge of the second slot comprises a second bump (latch 44_2, Annotated Fig 4), wherein the second bump (44_2, Annotated Fig 4) interferes with the second protrusion (33_2, Annotated Fig 3) to resist rotation of the cap (50) in the second direction (counterclockwise) ([0023]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber/Karthikeyan with similar locking mechanism comprising ledges and bump as taught by Weber for the purpose of securing the components and provide an audible and haptic feedback when the contact parts reach the locking position ([0023]).
Regarding claim 4, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 1. Abitabilo is silent wherein the first slot comprises a longitudinal edge opposite another longitudinal edge, wherein the longitudinal edge and the other longitudinal edge of the first slot are angled at a same angle as the first protrusion.
Weber discloses wherein the first slot (2004, Annotated Fig 4) comprises a longitudinal edge (2008, Annotated Fig 4) opposite another longitudinal edge (2009, Annotated Fig 4), wherein the longitudinal edge (2008, Annotated Fig 4) and the other longitudinal edge (2009, Annotated Fig 4) of the first slot (2004, Annotated Fig 4) are angled at a same angle as the first protrusion (33_1, Annotated Fig 3) (Annotated Fig 3 and Fig 8 shows a cross-section of the device when the pin 33_1 is inserted in slot 2004, Annotated Fig 4. The longitudinal edges 2008 and 2009 have the same angle in relation to each other and to pin 33_1, the angle considered being relative to the longitudinal axis 2014, Annotated Fig 3).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber/Karthikeyan with the same angle between first pin and longitudinal edges as taught by Weber for the purpose of having alignment between the components of the locking mechanism to securing them and prevent unwanted disconnection ([0043]; [0119]: “A maximum security against disconnection on suddenly occurring tensile stresses is ensured by the principle of the bayonet connection”)
Regarding claim 5, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 4. Abitabilo is silent wherein the second slot comprises a longitudinal edge opposite another longitudinal edge, wherein the longitudinal edge and the other longitudinal edge of the second slot are angled at a same angle as the second protrusion.
Weber teaches wherein the second slot (2005, Annotated Fig 4) comprises a longitudinal edge (2010, Annotated Fig 4) opposite another longitudinal edge (2011, Annotated Fig 4), wherein the longitudinal edge (2010, Annotated Fig 4) and the other longitudinal edge (2011, Annotated Fig 4) of the second slot (2005, Annotated Fig 4) are angled at a same angle as the second protrusion (33_2, Annotated Fig 3) (Annotated Fig 3 and Fig 8 shows a cross-section of the device when the pin 33_2 is inserted in slot 2005, Annotated Fig 4. The longitudinal edges 2010 and 2011 have the same angle in relation to each other and to pin 33_2, the angle considered being relative to the longitudinal axis 2014, Annotated Fig 3).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber/Karthikeyan with the same angle between first pin and longitudinal edges as taught by Weber for the purpose of having alignment between the components of the locking mechanism to securing them and prevent unwanted disconnection ([0043]; [0119]: “A maximum security against disconnection on suddenly occurring tensile stresses is ensured by the principle of the bayonet connection”)
Regarding claim 6, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 1. Abitabilo is silent wherein the first protrusion is opposite the second protrusion.
Weber teaches wherein the first protrusion (33_1, Annotated Fig 3) is opposite the second protrusion (33_2, Annotated Fig 3).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber/Karthikeyan with similar opposite protrusions as taught by Weber for the purpose of securing the components together and prevent unwanted disconnection ([0043]; [0119]: “A maximum security against disconnection on suddenly occurring tensile stresses is ensured by the principle of the bayonet connection”)
Regarding claim 7, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 1. Abitabilo is silent wherein the first slot is disposed on a same side of the first arm as the second slot is disposed on the second arm.
Weber teaches wherein the first slot (2004, Annotated Fig 4) is disposed on a same side of the first arm (2002, Annotated Fig 4) as the second slot (2005, Annotated Fig 4) is disposed on the second arm (2002, Annotated Fig 4).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber/Karthikeyan with similar position of the slots relative to the arms as taught by Weber for the purpose of securing the components together and prevent unwanted disconnection ([0043]; [0119]: “A maximum security against disconnection on suddenly occurring tensile stresses is ensured by the principle of the bayonet connection”)
Regarding claim 9, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 1. Abitabilo is silent wherein in a distal end view, the first direction is clockwise, wherein the second direction is counterclockwise.
Weber teaches wherein in a distal end view, the first direction is clockwise, wherein the second direction is counterclockwise (View of Fig 7 seen from distal top end); the first direction is the locking direction which is clockwise and the second direction, which is the unlocking direction is counterclockwise).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber/Karthikeyan with similar locking mechanism directions as taught by Weber for the purpose of locking and unlocking the components together at opposite directions in a secured manner ([0043]; [0119]: “A maximum security against disconnection on suddenly occurring tensile stresses is ensured by the principle of the bayonet connection”).
Regarding claim 10, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 1. Abitabilo discloses wherein the cap (120) further comprises a plurality of vents (pores of barrier 198, Fig 30A) disposed on an outer surface of the male luer (pores at the proximal end of the barrier 198 are located on an outer surface of the male luer connector 196; [0173]), wherein the vents (pores; [0173]) are sized to allow air but not liquid to pass ([0173]), wherein the plurality of vents extend out of the female luer adapter (118) (Fig 30B).
Regarding claim 11, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 1. Abitabilo discloses wherein a distal end of the first arm (204_1, Annotated Fig 2) is chamfered, wherein a distal end of the second arm(204_2, Annotated Fig 2) is chamfered (Fig 29B shows a chamfer at each of the engagement arms).
Regarding claim 12, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 1. Abitabilo discloses wherein the first arm (204_1, Annotated Fig 2) is spaced apart from the second arm (204_2, Annotated Fig 2) by a gap (1004, Annotated Fig 5) and another gap (1005, Annotated Fig 5) opposing the gap (1004, Annotated Fig 4).
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Abitabilo is silent wherein in response to rotation of the cap with respect to the female luer adapter in the second direction opposite the first direction and removal of the first protrusion from the first slot and the second protrusion from the second slot, the first protrusion is configured to be disposed within the gap and the second protrusion is configured to be disposed within the other gap, and the cap is configured to be removed from the female luer adapter.
Weber teaches wherein in response to rotation of the cap (50) with respect to the female luer adapter (10) in the second direction (counterclockwise) opposite the first direction (clockwise) and removal of the first protrusion (33_1, Annotated Fig 3) from the first slot (2004, Annotated Fig 4) and the second protrusion (33_2, Annotated Fig 3) from the second slot (2004, Annotated Fig 4), the first protrusion (33_1, Annotated Fig 3) is configured to be disposed within the gap (2012, Annotated Fig 4) and the second protrusion (33_2, Annotated Fig 3) is configured to be disposed within the other gap (2013, Annotated Fig 4), and the cap (50) is configured to be removed from the female luer adapter (10) (Fig 7).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber similar locking mechanism of cap slots and gaps coupled with the protrusion of the adapter as taught by Weber for the purpose of locking and unlocking the components together at opposite directions, and securing them to prevent unwanted disconnection ([0043]; [0119]: “A maximum security against disconnection on suddenly occurring tensile stresses is ensured by the principle of the bayonet connection”).
Regarding claim 21, Abitabilo discloses a catheter system (catheter assembly 100, Fig 2A), comprising: a catheter (catheter tube 108, Fig 4A); a female luer adapter (needleless connector 118 including luer connector 119, Fig 27A) comprising a proximal end (1001, Annotated Fig 1) and a distal end (1002, Annotated Fig 1); wherein the female luer adapter (118) is in fluid communication with the catheter (108); a cap (vent cap 120, Fig 28) that is configured to be secured to the female luer adapter (118, Fig 30A-B) to function as a vent plug for the female luer adapter (118) ([0172]), the cap (120) comprising: a top (1003, Annotated Fig 2); a male luer (nose 196, Fig 30B) extending distally from the top (1003, Annotated Fig 2) and inserted into the proximal end (1001, Annotated Fig 1) of the female luer adapter (118) to function as the vent plug ([0172]); a first arm (204_1, Annotated Fig 2) extending distally from the top (1003, Annotated Fig 2) along a longitudinal axis (L, Annotated Fig 2) of the cap (120) to define a length of the first arm (2000, Annotated Fig 2); a second arm (204_1, Annotated Fig 2) extending distally from the top (1003, Annotated Fig 2) along the longitudinal axis (L, Annotated Fig 2) of the cap (120) to define a length (2001, Annotated Fig 2) of the second arm (204_1, Annotated Fig 2), wherein a diameter (OD1, Annotated Fig 2) of the male luer (196) is configured to substantially match an inner diameter of the female luer adapter (118) when the male luer (196) has been inserted into the female luer adapter (118) to a third distance (fully insertion distance (FID), Fig 30B).
Abitabilo is silent wherein the proximal end comprises a first protrusion and a second protrusion that extend radially outwardly from a longitudinal axis of the female luer adapter to define a threading of the female luer that is configured to receive a male luer lock connector, wherein radial edges of the first and second protrusions are positioned at a first radial distance from the longitudinal axis of the female luer adapter, wherein the first comprises a first slot; wherein the second arm comprises a second slot; wherein each of the first and second slots are positioned at a second distance from the top along the longitudinal axis of the cap, the second distance being less than the lengths of the first and second arms; wherein each of the first and second slots are positioned at a second radial distance from the longitudinal axis of the cap, the second radial distance being less than the first radial distance; and wherein, wherein the male luer (196) is inserted to the third distance (FID), the first and second slots align with the first and second protrusions along a plane that is perpendicular to the longitudinal axes of the female luer adapter and the cap; wherein in response to rotation of the cap with respect to the female luer adapter in a first direction, the first protrusion inserts into the first slot until contacting an end of the first slot and the second protrusion insets into the second slot until contacting is an end of the second slot to prevent further rotation of the cap in the first direction and to prevent the cap from being removed from the female luer adapter due to the radial edges of the first and second protrusions being positioned at the first radial distance which is greater than the second radial distance at which the first and second slot are positioned, wherein in response to rotation of the cap with respect to the female luer adapter in a second direction opposite the first direction, the first protrusion is configured to be removed from the first slot and the second protrusion is configured to be removed from the second slot to thereby allow the cap to be removed from the female luer adapter by pulling the cap proximally relative to the female luer adapter.
Weber teaches a female luer adapter (base body 10, Fig 1; [0078]) wherein the proximal end (2001, Annotated Fig 3) of the female luer adapter (10) comprises a first protrusion (33_1, Annotated Fig 3) and a second protrusion (33_2, Annotated Fig 3) that extend radially outwardly from a longitudinal axis (2014, Annotated Fig 3) of the female luer adapter (10) that is configured to receive a male luer lock connector (50), wherein radial edges (Annotated Fig 3) of the first (33_1, Annotated Fig 3) and second protrusions (33_2, Annotated Fig 3) are positioned at a first radial distance (D1, Annotated Fig 3) from the longitudinal axis (2014, Annotated Fig 3) of the female luer adapter (10), wherein the first arm (2002, Annotated Fig 4) comprises a first slot (2004, Annotated Fig 4); wherein the second arm (2003, Annotated Fig 4) comprises a second slot (2005, Annotated Fig 4); wherein each of the first (2005, Annotated Fig 4) and second slots (2005, Annotated Fig 4) are positioned at a second distance (D2, Annotated Fig 3) from the top (3000, Annotated Fig 3) along the longitudinal axis of the cap (Longitudinal axis 2014, Annotated Fig 3), the second distance (D2, Annotated Fig 3) being less than the lengths of the first (L1, Annotated Fig 3)and second arms (L1, annotated Fig 3); wherein each of the first (2004, Annotated Fig 4) and second slots (2005, Annotated Fig 4) are positioned at a second radial distance (RD2, Annotated Fig 3) from the longitudinal axis (2014, Annotated Fig 3) of the cap (50), the second radial distance (RD2, Annotated Fig 3) being less than the first radial distance (RD1, Annotated Fig 3); and wherein, wherein the male luer is inserted to the third distance (insertion distance, Fig 8 shows the two parts after insertion), the first (2004, Annotated Fig 4) and second slots (2005, Annotated Fig 4) align with the first (33_1, Annotated Fig 3) and second protrusions (33_2, Annotated Fig 3) along a plane (plane show in Fig 8) that is perpendicular to the longitudinal axes (2014, Annotated Fig 3) of the female luer adapter (10) and the cap (50); wherein in response to rotation of the cap (50) with respect to the female luer adapter (10) in a first direction (clockwise), the first protrusion (33_1, Annotated Fig 3) inserts into the first slot (2004, Annotated Fig 4) until contacting an end (2006, Annotated Fig 4)of the first slot (end of slot as contacts the end of protrusion as seen in Fig 7) and the second protrusion (33_2, Annotated Fig 3) insets into the second slot (2005, Annotated Fig 4) until contacting is an end (2007, Annotated Fig 4) of the second slot (2005, Annotated Fig 4) to prevent further rotation of the cap (50) in the first direction (Clockwise) and to prevent the cap (50) from being removed from the female luer adapter (10) due to the radial edges of the first (2016_1, Annotated Fig 3) and second protrusions (2016_2, Annotated Fig 3) being positioned at the first radial distance (RD1, Annotated Fig 3) which is greater than the second radial distance (RD2, Annotated Fig 3) at which the first (2004, Annotated Fig 4) and second slot are positioned (2005, Annotated Fig 4), wherein in response to rotation of the cap (50) with respect to the female luer adapter (10) in a second direction (counterclockwise) opposite the first direction (clockwise), the first protrusion (33_1, Annotated Fig 3) is configured to be removed from the first slot (2004, Annotated Fig 4) and the second protrusion (33_2, Annotated Fig 3) is configured to be removed from the second slot (2005, Annotated Fig 4) to thereby allow the cap (50) to be removed from the female luer adapter (10) by pulling the cap (50) proximally relative to the female luer adapter (10).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo with similar locking mechanism of the arms of cap with the protrusion of the adapter as taught by Weber for the purpose of enhancing securing the components together and prevent unwanted disconnection ([0043]; [0119]: “A maximum security against disconnection on suddenly occurring tensile stresses is ensured by the principle of the bayonet connection”)
Abitabilo/Weber are silent wherein the first and the second protrusion define a threading of the female luer.
Karthikeyan teaches a catheter system (catheter system 10, Fig 1) comprising a female luer adapter (adapter 30, Fig 4A) wherein a first protrusion (3001, Annotated Fig 6) and the second protrusion (3002, Annotated Fig 6) define a threading (threads 32, Fig 2E; [0051]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber with similar protrusions on a threading as taught by Karthikeyan for the purpose of having a threading protrusion to increase the surface and time of contact when the protrusion passes through the bump of the slots, to further secure the engaging components ([0053]).
Regarding claim 22, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 21. Abitabilo is silent wherein the first slot comprises a longitudinal edge opposite another longitudinal edge, wherein the longitudinal edge or the other longitudinal edge of the first slot comprises a first bump, wherein the first bump interferes with the first protrusion to resist rotation of the cap in the second direction.
Weber teaches wherein the first slot (2004, Annotated Fig 4) comprises a longitudinal edge (2008, Annotated Fig 4) opposite another longitudinal edge (2009, Annotated Fig 4), wherein the longitudinal edge (2008, Annotated Fig 4) or the other longitudinal edge of the first slot (2004, Annotated Fig 4) comprises a first bump (latch 44, Fig 4), wherein the first bump (44) interferes with the first protrusion (33_1, Annotated Fig 3) to resist rotation of the cap (50) in the second direction (counterclockwise) ([0023]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber/Karthikeyan with similar locking mechanism comprising ledges and bump as taught by Weber for the purpose of securing the components and provide an audible and haptic feedback when the contact parts reach the locking position ([0023]).
Regarding claim 23, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 22. Abitabilo is silent wherein the second slot comprises a longitudinal edge opposite another longitudinal edge, wherein the longitudinal edge or the other longitudinal edge of the second slot comprises a second bump, wherein the second bump interferes with the second protrusion to resist rotation of the cap in the second direction.
Weber wherein teaches the second slot (2005, Annotated Fig 4) comprises a longitudinal edge (2010, Annotated Fig 4) opposite another longitudinal edge (2011, Annotated Fig 4), wherein the longitudinal edge (2010, Annotated Fig 4) or the other longitudinal edge of the second slot comprises a second bump (latch 44_2, Annotated Fig 4), wherein the second bump (44_2, Annotated Fig 4) interferes with the second protrusion (33_2, Annotated Fig 3) to resist rotation of the cap (50) in the second direction (counterclockwise) ([0023]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber/Karthikeyan with similar locking mechanism comprising ledges and bump as taught by Weber for the purpose of securing the components and provide an audible and haptic feedback when the contact parts reach the locking position ([0023]).
Regarding claim 24, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 21. Abitabilo is silent wherein the first slot comprises a longitudinal edge opposite another longitudinal edge, wherein the longitudinal edge and the other longitudinal edge of the first slot are angled at a same angle as the first protrusion.
Weber discloses wherein the first slot (2004, Annotated Fig 4) comprises a longitudinal edge (2008, Annotated Fig 4) opposite another longitudinal edge (2009, Annotated Fig 4), wherein the longitudinal edge (2008, Annotated Fig 4) and the other longitudinal edge (2009, Annotated Fig 4) of the first slot (2004, Annotated Fig 4) are angled at a same angle as the first protrusion (33_1, Annotated Fig 3) (Annotated Fig 3 and Fig 8 shows a cross-section of the device when the pin 33_1 is inserted in slot 2004, Annotated Fig 4. The longitudinal edges 2008 and 2009 have the same angle in relation to each other and to pin 33_1, the angle considered being relative to the longitudinal axis 2014, Annotated Fig 3).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber/Karthikeyan with the same angle between first pin and longitudinal edges as taught by Weber for the purpose of having alignment between the components of the locking mechanism to securing them and prevent unwanted disconnection ([0043]; [0119]: “A maximum security against disconnection on suddenly occurring tensile stresses is ensured by the principle of the bayonet connection”)
Regarding claim 25, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 24. Abitabilo is silent wherein the second slot comprises a longitudinal edge opposite another longitudinal edge, wherein the longitudinal edge and the other longitudinal edge of the second slot are angled at a same angle as the second protrusion.
Weber teaches wherein the second slot (2005, Annotated Fig 4) comprises a longitudinal edge (2010, Annotated Fig 4) opposite another longitudinal edge (2011, Annotated Fig 4), wherein the longitudinal edge (2010, Annotated Fig 4) and the other longitudinal edge (2011, Annotated Fig 4) of the second slot (2005, Annotated Fig 4) are angled at a same angle as the second protrusion (33_2, Annotated Fig 3) (Annotated Fig 3 and Fig 8 shows a cross-section of the device when the pin 33_2 is inserted in slot 2005, Annotated Fig 4. The longitudinal edges 2010 and 2011 have the same angle in relation to each other and to pin 33_2, the angle considered being relative to the longitudinal axis 2014, Annotated Fig 3).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber/Karthikeyan with the same angle between first pin and longitudinal edges as taught by Weber for the purpose of having alignment between the components of the locking mechanism to securing them and prevent unwanted disconnection ([0043]; [0119]: “A maximum security against disconnection on suddenly occurring tensile stresses is ensured by the principle of the bayonet connection”)
Regarding claim 26, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 21. Abitabilo is silent wherein the first protrusion is opposite the second protrusion.
Weber teaches wherein the first protrusion (33_1, Annotated Fig 3) is opposite the second protrusion (33_2, Annotated Fig 3).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber/Karthikeyan with similar opposite protrusions as taught by Weber for the purpose of securing the components together and prevent unwanted disconnection ([0043]; [0119]: “A maximum security against disconnection on suddenly occurring tensile stresses is ensured by the principle of the bayonet connection”)
Regarding claim 27, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 21. Abitabilo is silent wherein the first slot is disposed on a same side of the first arm as the second slot is disposed on the second arm.
Weber teaches wherein the first slot (2004, Annotated Fig 4) is disposed on a same side of the first arm (2002, Annotated Fig 4) as the second slot (2005, Annotated Fig 4) is disposed on the second arm (2002, Annotated Fig 4).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber/Karthikeyan with similar position of the slots relative to the arms as taught by Weber for the purpose of securing the components together and prevent unwanted disconnection ([0043]; [0119]: “A maximum security against disconnection on suddenly occurring tensile stresses is ensured by the principle of the bayonet connection”)
Regarding claim 28, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 21. Abitabilo is silent wherein in a distal end view, the first direction is clockwise, wherein the second direction is counterclockwise.
Weber teaches wherein in a distal end view, the first direction is clockwise, wherein the second direction is counterclockwise (View of Fig 7 seen from distal top end); the first direction is the locking direction which is clockwise and the second direction, which is the unlocking direction is counterclockwise).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abitabilo/Weber/Karthikeyan with similar locking mechanism directions as taught by Weber for the purpose of locking and unlocking the components together at opposite directions in a secured manner ([0043]; [0119]: “A maximum security against disconnection on suddenly occurring tensile stresses is ensured by the principle of the bayonet connection”).
Regarding claim 29, Abitabilo/Weber/Karthikeyan discloses the catheter system of claim 21. Abitabilo discloses wherein the cap (120) further comprises a plurality of vents (pores of barrier 198, Fig 30A) disposed on an outer surface of the male luer (pores at the proximal end of the barrier 198 are located on an outer surface of the male luer connector 196; [0173]), wherein the vents (pores; [0173]) are sized to allow air but not liquid to pass ([0173]), wherein the plurality of vents extend out of the female luer adapter (118) (Fig 30B).
Response to Arguments
Applicant’s arguments with respect to claims 1-7, 9-12, and 21-29 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Please refer to claim rejection of relevant claims for disclosure of claim amendments. Figures have also been updated to reflect the amended claim limitations.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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