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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 30, 2026 has been entered.
Response to Amendment
The amendment filed June 30, 2026 has been entered. Claims 1-3, 5-6, and 8 remain pending in the application. Claims 4, 7, and 9-28 have been cancelled. Applicant’s amendments to the claims have overcome the rejections under 35 USC 112 previously set forth in the Final Rejection mailed March 31, 2026.
Claim Objections
Claim1 is objected to because there is a lack of antecedent basis for “the entirety of the arced edge” in line 15. 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 1-3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Ebner et al. (US 2020/0338314) in view of Neoh et al. (US 20170232231).
Regarding claim 1, Ebner discloses a catheter assembly (Figure 7A, specifically: “In various embodiments, the hinging push tab 701 does not include a resilient portion 723. After threading the catheter and removing the needle from the catheter hub 785, the hinging push tab 701 may be flipped down to simply lay flat against the catheter hub 785. In these embodiments, once down, push tab 701 is out of the way, improving the ability to dress the catheter.” [0084]), comprising:
a catheter adapter (catheter hub 785), comprising a distal end (distal end of hub 785), a proximal end (proximal portion 786), and a lumen extending between the distal end and the proximal end (see Figure 7A(B)); and
a push tab (hinging push tab 701) pivotally coupled to the catheter adapter (“the hinging push tab 701 can pivot or hinge about its point of fixation, starting in the vertical position, but after the needle and TPA are removed, the hinging push tab 701 flips down or can be manually flipped down” [0082]; “After threading the catheter and removing the needle from the catheter hub 785, the hinging push tab 701 may be flipped down to simply lay flat against the catheter hub 785.” [0084]), wherein the push tab is pivotally moveable between a raised position (Figure 7A) and a depressed position (“In various embodiments, the hinging push tab 701 does not include a resilient portion 723. After threading the catheter and removing the needle from the catheter hub 785, the hinging push tab 701 may be flipped down to simply lay flat against the catheter hub 785. In these embodiments, once down, push tab 701 is out of the way, improving the ability to dress the catheter.” [0084]).
Ebner fails to explicitly disclose the catheter adapter comprising two opposing indents; and the push tab comprising two opposing protrusions formed integrally with the push tab and disposed within the two opposing indents of the catheter adapter to pivotally couple the push tab to the catheter adapter, wherein the push tab comprises an arced edge extending between the two opposing protrusions, wherein the raised position is defined by engagement of substantially the entirety of the arced edge with an upper surface of the catheter adapter, wherein the arced edge functions as a stop surface limiting further pivotal movement of the push tab beyond the raised position, and wherein the opposing protrusions define a pivot axis located below the upper surface of the catheter adapter.
Neoh teaches a catheter assembly (catheter hub assembly 100 and tubular member 106), comprising: a catheter adapter (catheter hub assembly 100) comprising two opposing indents (left and right openings of hole: “the hub body 102 defines a hole” [0035]); and a push tab (lever arm 108) comprising two opposing protrusions (left and right side of post: “lever arm 108 includes a post to connect the lever arm 108 to the hub body 102.” [0035]) formed integrally with the push tab (“lever arm 108 includes a post” [0035], wherein the disclosed post is part of, or integral with the lever arm 108) and disposed within the two opposing indents of the catheter adapter (“Each of the right and left faces 122 and 124, respectively, include a post 126 positioned closer to the proximal end 112” [0030]; “The lever arm 108 includes a hole 164 that is sized and positioned to receive the post 126 therein to attach the lever arm 108 to the hub body 102. Alternatively, the hub body 102 defines a hole and the lever arm 108 includes a post to connect the lever arm 108 to the hub body 102.” [0035]) to pivotally couple the push tab to the catheter adapter (Figures 1-4), wherein the push tab comprises an arced edge (recessed portion 165, shown arced in Figures 1 and 2) extending between the two opposing protrusions (Figure 1), wherein the push tab is pivotally moveable between a raised position (Figure 2) and a depressed position (Figure 1), wherein the raised position (Figure 2) is defined by engagement of substantially the entirety of the arced edge with an upper surface (protrusion 144) of the catheter adapter (Figures 1-2; “The lever arm 108 has a recessed portion 165 that is configured to slide over or rotate about the protrusion 144 when the lever arm 108 rotates about the post 126.” [0035]; Figure 2 showing the recessed portion 165 in full contact with the protrusion 144 in the raised position), wherein the arced edge functions as a stop surface limiting further pivotal movement of the push tab beyond the raised position (Figure 2, showing that the recessed portion 165 would contact the radially extending distal end of the hub body 102 preventing further pivotal movement), and wherein the opposing protrusions define a pivot axis located below the upper surface of the catheter adapter (Figures 1 and 2).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the pivoting connection of the push tab pivotally coupled to the catheter adapter of Ebner to include the catheter adapter comprising two opposing indents; and the push tab comprising two opposing protrusions formed integrally with the push tab and disposed within the two opposing indents of the catheter adapter to pivotally couple the push tab to the catheter adapter, wherein the push tab comprises an arced edge extending between the two opposing protrusions, wherein the raised position is defined by engagement of substantially the entirety of the arced edge with an upper surface of the catheter adapter, wherein the arced edge functions as a stop surface limiting further pivotal movement of the push tab beyond the raised position, and wherein the opposing protrusions define a pivot axis located below the upper surface of the catheter adapter based on the teachings of Neoh to pivotally couple the push tab to the catheter adapter in a manner that allows the push tab to easily rotate between the raised and depressed positions (Neoh [0035]) to ensure that the push tab lies flat against the catheter adapter in the depressed position in order to facilitate placement of a dressing, prevent damage to the dressing, and minimize dead space under the dressing that can lead to contamination (Ebner [0053], [0084]).
Regarding claim 2, modified Ebner teaches the catheter assembly of claim 1, wherein the push tab (push tab 701) comprises a first end (lower portion of push tab 701 attached to catheter hub 785) and a second end (upper portion of push tab 701 away from catheter hub 785) opposite the first end (Figure 7A), wherein the first end is pivotally coupled to the catheter adapter (Figures 7A(A)-(C)), wherein the second end is further from the catheter adapter when the push tab is in the raised position (Figure 7A(A)) than when the push tab is in the depressed position (Figure 7B for example, “In various embodiments, the hinging push tab 701 does not include a resilient portion 723. After threading the catheter and removing the needle from the catheter hub 785, the hinging push tab 701 may be flipped down to simply lay flat against the catheter hub 785.” [0084]).
Modified Ebner fails to explicitly teach wherein the first end comprises the two opposing protrusions.
Neoh teaches a catheter assembly (catheter hub assembly 100 and tubular member 106), comprising: a catheter adapter (catheter hub assembly 100); and a push tab (lever arm 108); wherein the push tab comprises two opposing protrusions (left and right side of post: “lever arm 108 includes a post to connect the lever arm 108 to the hub body 102.” [0035]), wherein the push tab comprises a first end (at holes 164) and a second end opposite the first end (at rear tab 176), the first end comprising the two opposing protrusions and is pivotally coupled to the catheter adapter (“Each of the right and left faces 122 and 124, respectively, include a post 126 positioned closer to the proximal end 112” [0030]; “The lever arm 108 includes a hole 164 that is sized and positioned to receive the post 126 therein to attach the lever arm 108 to the hub body 102. Alternatively, the hub body 102 defines a hole and the lever arm 108 includes a post to connect the lever arm 108 to the hub body 102.” [0035]; Figures 1-2).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the catheter adapter having a push tab of Ebner to include the first end of the push tab comprises the two opposing protrusions based on the teachings of Neoh to pivotally couple the push tab to the catheter adapter in a manner that allows the push tab to easily rotate between the raised and depressed positions (Neoh [0035]) to ensure that the push tab lies flat against the catheter adapter in the depressed position in order to facilitate placement of a dressing, prevent damage to the dressing, and minimize dead space under the dressing that can lead to contamination (Ebner [0053], [0084]).
Regarding claim 3, modified Ebner teaches the catheter assembly of claim 2, wherein the second end (upper portion of push tab 701 away from catheter hub 785) is disposed in a first position in response to the push tab being in the raised position (Figure 7A), wherein the second end is disposed in a second position in response to the push tab being in the depressed position, wherein the second position is proximal to the first position (Figure 7A-7B; “In various embodiments, the hinging push tab 701 does not include a resilient portion 723. After threading the catheter and removing the needle from the catheter hub 785, the hinging push tab 701 may be flipped down to simply lay flat against the catheter hub 785.” [0084]).
Regarding claim 5, modified Ebner teaches the catheter assembly of claim 1, wherein in response to the push tab being in the raised position (Figure 7A), the push tab is perpendicular to a longitudinal axis of the catheter adapter (“the push tab extending radially from the outer surface of the tubular housing at an angle to the central axis…the angle is about 90° such that the distal face of the push tab is flush with the distal circumferential opening of the tubular housing.” [0006-0007]; Figure 7A).
Regarding claim 6, modified Ebner teaches the catheter assembly of claim 1, wherein in response to the push tab being in the depressed position, the push tab is generally aligned with a longitudinal axis of the catheter adapter (“After threading the catheter and removing the needle from the catheter hub 785, the hinging push tab 701 may be flipped down to simply lay flat against the catheter hub 785.” [0084]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ebner et al. (US 2020/0338314) in view of Neoh et al. (US 20170232231) as applied in claim 1 above, and further in view of Moulton et al. (US 2004/0102735).
Regarding claim 8, modified Ebner teaches the catheter assembly of claim 1.
Modified Ebner fails to explicitly teach wherein a proximal surface of the push tab is concave.
Moulton teaches a catheter assembly (catheter assembly 20 and introducer needle assembly 30) comprising a catheter adapter (catheter adapter 24) comprising a distal end, a proximal end (Figure 1) and a push tab (push tab 48) coupled to the catheter adapter (Figure 1), wherein a proximal surface of the push tab is concave (“The upstanding tab portion has…a concave proximal face 149.” [0027]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the catheter assembly of Ebner to include the proximal surface of the push tab is concave based on the teachings of Moulton to enhance the comfort and ease of use for the user (Moulton [0028]).
Response to Arguments
Applicant’s arguments with respect to claims 1-3, 5-6, and 8 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.
Regarding the argument that the prior art of record fails to explicitly disclose or suggest "the raised position is defined by engagement of substantially the entirety of the arced edge with an upper surface of the catheter adapter” and “the arced edge functions as a stop surface limiting further pivotal movement of the push tab beyond the raised position” as required by amended claim 1 (Remarks Pages 6-7), the examiner respectfully disagrees. As detailed above, Neoh discloses a push tab (108) having a raised position (Figure 2) defined by engagement of substantially the entirety of the arced edge (165) with an upper surface (144) of the catheter adapter (Figures 1-2; “The lever arm 108 has a recessed portion 165 that is configured to slide over or rotate about the protrusion 144 when the lever arm 108 rotates about the post 126.” [0035]. Neoh in at least Figure 2 depicts the recessed portion 165 in full contact with the protrusion 144 in the raised position. Neoh additionally discloses that the arced edge (165) functions as a stop surface limiting further pivotal movement of the push tab beyond the raised position (Figure 2, showing that the recessed portion 165 would contact the radially extending distal end of the hub body 102 preventing further pivotal movement).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783
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