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 .
Election/Restrictions
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/27/2025.
Applicant’s election without traverse of claims 1-12 in the reply filed on 10/27/2025 is acknowledged.
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, and 9-12 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).
Regarding claim 1, Abitabilo discloses a catheter system (catheter assembly 100, Fig 2A), comprising: a catheter (catheter tube 108, Fig 3A); 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 proximal end (1001, Annotated Fig 1), wherein the female luer adapter (118) is in fluid communication with the catheter (108) (Fig 2A, tube 114 fluidly couples needleless connector 118 to catheter tube 108); a 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); a first arm (204_1, Annotated Fig 2) extending distally from the top (1003, Annotated Fig 2); a second arm (204_2, Annotated Fig 2) extending distally from the top (1003, Annotated Fig 2).
PNG
media_image1.png
548
976
media_image1.png
Greyscale
PNG
media_image2.png
922
708
media_image2.png
Greyscale
Abitabilo is silent wherein the proximal end comprises a first protrusion and a second protrusion; wherein the first arm comprises a first slot; the second arm comprises a second slot, wherein the first protrusion is disposed within the first slot and the second protrusion is disposed within the second slot, wherein in response to rotation of the cap with respect to the female luer adapter in a first direction, the first protrusion is configured to press against an end of the first slot and the second protrusion is configured to press against an end of the second slot to prevent further rotation of the cap in the first direction, 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.
Weber teaches a female luer adapter (10) comprising a proximal end (2001, Annotated Fig 3) wherein the proximal end (2001, Annotated Fig 3) comprises a first protrusion (pin 33_1, Annotated Fig 3; [0082]) and a second protrusion (pin 33_2, Annotated Fig 3; [0082]); wherein a first arm (2002, Annotated Fig 4) comprises a first slot (2004, Annotated Fig 4); the second arm (2003, Annotated Fig 4) comprises a second slot (2005, Annotated Fig 4), wherein the first protrusion (pin 33_1, Annotated Fig 3) is disposed within the first slot (2004, Annotated Fig 4) and the second protrusion (pin 33_2, Annotated Fig 3) is disposed within the second slot (2005, Annotated Fig 4), wherein in response to rotation of the cap (protective cap 50, Fig 5) with respect to the female luer adapter (body 10, Fig 5) in a first direction (clockwise), the first protrusion (33_1, Annotated Fig 3) is configured to press against an end (2006, Annotated Fig 4) of the first slot (2004, Annotated Fig 4) and the second protrusion (33_2, Annotated Fig 3) is configured to press against 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), 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).
PNG
media_image3.png
592
1541
media_image3.png
Greyscale
PNG
media_image4.png
759
1387
media_image4.png
Greyscale
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 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 2, Abitabilo/Weber 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 is interfering 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) is interfering 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 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 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 is interfering 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) is interfering 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 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 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 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 discloses 5. 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 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 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 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 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 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 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 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 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 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 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).
PNG
media_image5.png
435
702
media_image5.png
Greyscale
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”).
Claim 8 is 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 8, Abitabilo/Weber discloses the catheter system of claim 1. Abitabilo discloses wherein the proximal end (1001, Annotated Fig 1) of the female luer adapter (118) comprises a threading (threading of luer 119, Fig 27A). Abitabilo/Weber are silent wherein the first protrusion and the second protrusion are disposed on the threading.
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) are disposed on the threading (threads 32, Fig 2E; [0051]).
PNG
media_image6.png
897
818
media_image6.png
Greyscale
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])
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached on (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/Primary Examiner, Art Unit 3783