DETAILED ACTION
Response to Arguments
Applicant's arguments filed August 15, 2025 have been fully considered but they are not persuasive. Regarding Applicant’s arguments directed to the housing connection of Belson being modified, the Examiner respectfully disagrees. Belson discloses a multi-component housing assembly for controlling a guidewire during a procedure. Applicant contends that providing a rotating connection between the proximal and distal housing sections would destroy the function of the device of Belson, however, this is not found persuasive as the proximal housing (which is rotatable during distal movement of the guidewire actuator) may still be free to rotate while finding alignment with the needle carrier notch. The motivation to allow free movement of the proximal housing during insertion while retaining the function of connecting the slider to the carrier notch to secure the guidewire would be maintained. There would not be a misalignment if the housings can be rotated relative to one another as the securement means can still be achieved via alignment after insertion. The function of the device of Belson is to locate the catheter in a vein and moving the guidewire via the proximal housing allows for freedom to rotate and manipulate the device during guidewire insertion. The vasculature is not necessarily straight at any point of insertion and the motivation of using rotation to more accurately guide the guidewire during such an insertion procedure is considered relevant and a reasonable modification to such a device that one of ordinary skill in the art would seek to make when provided with the cited prior art references. Regarding the fluid-tightness of the device, Belson contemplates receiving flashback from the needle 7 (see ¶ [0030]) and so it would make sense for the rotatable seal between the proximal and distal housing assemblies to be fluid-tight to prevent any blood or other unwanted fluid from passing into the proximal housing during a procedure. The motivation is considered relevant to the disclosure of Belson and would be obvious for such reasons. Finally, Belson further contemplates separation of the proximal and distal housing portions during a procedure (see Figure 5; ¶ [0035]), and so any modification should maintain the ability of the proximal housing to be separated. The rejection is considered proper and is maintained below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 5, 6, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belson (US 2012/0197200) in view of Waldbillig (US 4,254,773), and further in view of Klinger (US 5,297,818).
Regarding claims 1, 5, and 6, Belson discloses an insertion device (20) for a medical article, comprising: a housing, including a proximal housing (22) coupled to a distal housing (distal section comprising button 25), the proximal housing including a longitudinal slot (22) configured to receive a slider assembly (slider 3); a needle (7) extending from a distal end of the distal housing (Figure 2); a catheter (100) coaxially aligned over the needle (e.g., Figure 2) and including a catheter tube (102) extending distally from a catheter hub (fitting 104), the catheter hub releasably engaged with the distal end of the housing (Figure 1; ¶ [0033]) and a guidewire (9; Figures 4-5) disposed within a lumen of the needle, and coupled with the slider assembly that is configured to advance the guidewire in a distal direction (¶¶ [0011] and [0024]). Belson fails to explicitly disclose the proximal housing to be rotatably coupled to the distal housing and the discontinuous flange as claimed.
Waldbillig teaches (Figure 2) a connector for a catheter system comprising a proximal housing (40) and a distal housing (20) which are connected via a rotatable connection (Figure 2; Abstract) to simultaneously allow free rotation (of the connector portion of the dilator which is considered as part of the proximal housing portion) about the longitudinal axis and inhibit movement along the longitudinal axis between the proximal housing and distal housing (Col. 1, lines 49-56; the connector inhibits axial movement beyond compression of the o-ring and allows for rotation between the two as per the cited paragraph).
Klinger teaches (Figures 1-3) a tubing connector comprising a proximal housing (female connector 16, 18, 10) comprising a flanged portion (e.g., comprising fingers 44 and 46) extending radially inwardly and extending discontinuously (e.g., it’s comprised of intermediate inward fingers around the circumference and the head portion of each finger extends radially inwardly as claimed in an elastically undeflected position as depicted in Figure 2; e.g., a portion of the head always extends radially inwardly relative to a longitudinal axis of the fingers) about a distal opening for engaging another element in a snap-fit engagement (male connector 14 forces fingers apart during insertion and the fingers subsequently lock about the flange to prevent premature removal). Klinger further teaches a retaining ring on the proximal housing which engages a proximal portion of the distal housing after connection (Figure 3). Klinger further teaches wherein the flange of the retaining ring is configured to engage an annular structure or slider on the proximal portion of the distal housing (flange 20 received in an open portion after connection as depicted in Figure 3).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the connection between the proximal and distal housing of Belson to comprise a rotatable connection so as to allow one of the connected housings to rotate relative to the other to aid in guiding a catheter through tortuous vasculature while retaining a fluid-tight connection between the housings as taught by Waldbillig (e.g., Col. 1, lines 9-21).
In addition, Belson/Waldbillig fail to disclose the discontinuous flange portion. However, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the proximal housing of Belson/Waldbillig to comprise the flange of Klinger as Klinger discloses that such a means is suitable for forming an engagement between two elements of a tubular structure to be used in fluid-tight connections. Such a connection means provides a fluid-tight fit with quick connection and disconnection properties allowing the tubing portions to be quickly and easily managed during a procedure as taught by Klinger (Col. 4, lines 37-64).
Regarding claim 2, Belson further discloses wherein the needle (7) is supported by a needle carrier that is slidably engaged with the housing (carrier 6; ¶ [0024]).
Regarding claim 3, Belson further discloses an actuator (button 25) disposed on the distal housing and a biasing member (spring 10) coupled to the needle carrier (6, ¶ [0028]), the needle carrier being urged in a proximal direction by activation of the actuator (the spring biases the carrier and slider in the proximal direction).
Regarding claim 15 Belson further discloses wherein the catheter hub (105) includes one of a side arm extension set (proximal fitting 104 and side arm tube 106; Figures 7-8).
Regarding claim 16, Belson further discloses wherein the catheter hub (105) includes the side- arm extension set (104, 106) and a bilaterally symmetrical proximal fitting (luer fitting 27; Figure 1), the catheter hub rotatable relative to the housing between a left-handed configuration and a right-handed configuration (see e.g., ¶ [0033] and Figure 1).
Regarding claim 17, Belson further discloses wherein the guidewire (9) includes a coil tip (spiral tip 28; Figure 12) transitionable between a straight configuration and a coiled configuration (e.g., ¶ [0025]).
Regarding claim 39, Klinger further teaches wherein the housing further includes a detent mechanism configured to bias a position of the proximal housing relative to the distal housing to one or more predetermined angles (the tip surfaces of fingers 44 and 46 act on the flange 20 to retain the two housing portions together after connection).
Claim(s) 7, 8, 35-38, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belson in view of Waldbillig in view of Klinger, and further in view of Lin (US 2007/02601901).
Regarding claims 7 and 8, Belson/Waldbillig/Klinger teach the claimed invention substantially as set forth above for claim 1, but fail to disclose the claimed gate structure.
Lin teaches a medical device comprising a slot (85) in a housing (81) wherein a proximal end of the slot includes a gate structure (e.g., teeth 851), the gate structure including a first gate and second gate (each of teeth 851) that are deflectable to allow distal ingress of another device into the slot (e.g., ¶ [0002]; Figures 8-9); wherein the first or second gate comprises an abutment surface (e.g., distal retaining surfaces of the teeth 851) to engage the other member to prevent proximal egress of the member from the slot (¶ [0002]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Belson/Waldbillig/Klinger to comprise the gate structure of Lin within the slot so as to substantially prevent inadvertent removal of the slider assembly from the proximal housing portion during use. In this manner a limit is set on the rearward movement of the slide assembly to maintain the slider within the housing throughout use as taught by Lin.
Regarding claims 35-38, Belson discloses a catheter placement device, comprising: a catheter (100); a needle (7); a guidewire (9); and a housing comprising: a slot (22; Figure 1) extending longitudinally; a slider assembly (slide 3) extending through the slot and configured to selectively advance the guidewire (¶¶ [0026] and [0035]). Klinger further teaches a distal housing; and a proximal housing rotatably coupled to the distal housing by a rotatable coupling including a series of flanges (25) disposed annularly about a distal opening of the proximal housing and engaging the distal housing in a snap- fit engagement (Figures 3 and 5). As set forth above, Belson fails to explicitly disclose the gate structure.
Lin teaches an insertion device comprising a housing (81) including a slot (85) configured to receive a slider assembly (e.g., wing 84, Figures 8-9; ¶ [0002]) wherein a proximal end of the slot comprises a gate structure (teeth 851) which comprises first and second gates which are deflectable laterally outwardly to allow distal ingress of the slider into the slot (e.g., Figures 8-9; ¶ [0002]); wherein the first or second gate comprise an abutment surface configured to engage the slider assembly to prevent proximal egress of the slider from the slot (e.g., distal engagement surface of teeth 851); wherein the first and second gate are configured to rotate laterally inwardly toward a central longitudinal axis to prevent further lateral rotation thereof and prevent proximal egress of the slider from the slot (it is understood from the instant disclosure e.g., at ¶ [0062] that the claimed rotation is based upon a radial force being applied to the housing to cause the first and second gates to deflect inwardly so as to abut each other to prevent any further lateral deflection; the gates of Lin are considered fully capable of preventing lateral deflection past a point in which the abut each other in substantially the same manner as that of the instant invention).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Belson/Waldbillig/Klinger to comprise the gate structure of Lin within the slot so as to substantially prevent inadvertent removal of the slider assembly from the proximal housing portion during use. In this manner a limit is set on the rearward movement of the slide assembly to maintain the slider within the housing throughout use as taught by Lin.
Regarding claim 40, Klinger further teaches wherein the housing further includes a detent mechanism configured to bias a position of the proximal housing relative to the distal housing to one or more predetermined angles (e.g., the depression of camming surfaces 25 to different angles as the two elements are connected is considered to meet the claim limitations as currently set forth.
Claim(s) 9, 10, and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belson in view of Waldbillig, in view of Klinger and further in view of Shaw (US 5,779,679).
Regarding claims 9 and 10, Belson/Waldbillig/Klinger teach the claimed invention substantially as set forth above for claim 1, and Belson further teaches a catheter advancement carrier (proximal fitting 104; Figure 5) disposed between the catheter hub (105) and the distal housing (e.g., Figure 4). Neither Belson nor Waldbillig nor Klinger teach first and second tabs.
Shaw teaches a medical insertion device (e.g., winged IV set 10; Figure 1) including first and second tabs (wings 18) which each extend perpendicular to the longitudinal axis of the device (Figures 1- 2) wherein the first and second tabs (18) include a fold line (54; Figure 6) to facilitate folding the tabs (e.g., Col. 7, lines 17-25).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Belson/Waldbillig/Klinger to comprise the first and second folding tabs of Shaw so as to facilitate the handling of the device during use (e.g., Shaw Col. 3, lines 26-32).
Regarding claim 12, Belson further discloses wherein the catheter hub (105) is releasably engaged with the catheter advancement carrier (104; e.g., ¶ [0037] discloses how the fitting 104 comprises a male luer connector 132 on the distal end that engages with a female connector 134 on a proximal end of the catheter tube 102).
Regarding claim 13, Belson further discloses wherein the catheter advancement carrier (104) is releasably engaged with the distal housing (e.g., ¶ [0033]; Figure 1; the advancement carrier comprises luer fitting 27 for engaging the distal housing).
Regarding claim 14, Belson further discloses wherein the advancement carrier (104) is rotatably engaged with the distal housing (luer fitting 27 engages the distal housing in a rotatable manner as claimed).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belson in view of Waldbillig in view of Klinger in view of Shaw, and further in view of O’Bryan et al. (US 2017/0274182).
Regarding claim 11, Belson/Waldbillig/Klinger/Shaw teach the claimed invention substantially as set forth above for claim 9, but fail to explicitly disclose a gripping feature on the catheter advancement carrier.
O’Bryan et al. (henceforth O’Bryan) teaches an insertion device (Figure 1) comprising a first tab (grip 152) extending perpendicular to the longitudinal axis of the device and wherein the tab comprises a gripping feature (170, Figure 1).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the insertion device of Belson/Waldbillig/Klinger/Shaw to comprise the gripping feature of O’Bryan so as to allow a user a secure interface which facilitates gripping and manipulation of the advancement carrier during use as taught by O’Bryan (e.g., ¶ [0035]).
Conclusion
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783