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
Applicant’s election without traverse of Invention I, Species a., Fig. 23a, relating to claims 1-8, 14-15, in the reply filed on 3/17/26 is acknowledged.
Claims 9-13, 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group and Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/17/26.
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) 1-5, 14, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard (US 2014/0094774 A1) in view of Drontle et al. (US 2010/0312101 A1).
With regard to claim 1, Blanchard discloses A catheter insertion device assembly (Fig. 1a, 1b), comprising: a catheter (42) including a catheter tube (44) defining a catheter lumen (inherent) extending between a catheter distal (where 16 is pointing in Fig. 1b) end and a catheter hub (46) at a catheter proximal end (see Fig. 1b), the catheter hub disposed within a housing (12, which includes 12a and 12b); a needle (16) configured for insertion into a patient between a skin surface and a blood vessel ([0051]), the needle defining a needle lumen (inherent, also [0051], needle is designed to receive blood) extending between a needle distal end (where 16 is pointing in Fig. 1b) and a needle proximal end (at needle hub 14) coupled with the housing (see Fig. 1b showing 14 touch 1b), wherein the needle is pre-disposed within the catheter lumen such that the needle distal end extends beyond the catheter distal end and the needle proximal end extends proximally beyond the catheter hub (see Fig. 1b, [0003]); a guidewire (22) extending between a guidewire distal end (inherent) and a guidewire proximal portion (inherent), wherein the guidewire is pre-disposed within the needle lumen(see Fig. 1b, [0052]) such that the guidewire distal end is positioned proximal the needle distal end ([0052]) and the guidewire proximal portion extends proximally beyond the needle proximal end ([0052]); and a slide (28) displaceable along an exterior of the housing (see Fig. 1b), the slide coupled with the guidewire proximal portion (generally at 26) such that a displacement of the slide causes a displacement of the guidewire ([0053]).
However, Blanchard does not disclose a mechanical advantage mechanism.
Drontle teaches a similar catheter insertion system (Fig. 1) having a catheter (30) with an inner guide which can be considered equivalent to the needle (14) and a slide (32) for moving the catheter distally and proximally. Drontle further includes and a mechanical advantage mechanism (Fig 4, element 52, [0038], considered a mechanical advantage because it “facilitates distal advancement of the shaft 30) coupled between the slide (32) and the catheter hub (Fig. 4, element 38) such that: the slide provides an input force to the mechanical advantage mechanism ([0038], helical portion 52 expands and contracts based on the movement of the knob 32), and the mechanical advantage mechanism provides an output force to the catheter hub in response to the input force, the output force greater than the input force ([0038], the helical component 52 provides an output force greater than the input force because it takes the mechanical advantage of the spring-like nature to facilitate or assist in the distal movement of the shaft 30 as described in [0038]). The helical element 52 can be added inside the housing of Blanchard to the slide mechanism of Blanchard such that when the slide is moved distally, the helical element 52 would provide an additional mechanical advantage for moving a shaft distally.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Blanchard with the mechanical advantage as taught by Drontle for the purpose of facilitating distal advancement of a shaft ([0038]).
With regard to claim 2, Blanchard discloses wherein the input force is distally oriented (the slide 28 moves distally to move the guidewire)
However, Blanchard does not disclose the mechanical advantage mechanism and the output force.
Drontle teaches wherein the input force and the output force are each distally oriented (the slide 32 moves distally creating an input force that moves the helical element 52 distally which creates the output force).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Blanchard with the mechanical advantage as taught by Drontle for the purpose of facilitating distal advancement of a shaft ([0038]).
With regard to claim 3, Blanchard/Drontle teach the claimed invention including an input and output force where the output force is greater (see rejection of claim 1). While Blanchard/Drontle do not explicitly teach that the output force is greater than the input force by a factor of two, it would be prima facie obvious to optimize the factor to be two as doing so would not alter the overall function of the device.
With regard to claim 4, Blanchard discloses wherein the displacement of the slide causes a displacement of the catheter and a simultaneous displacement of the guidewire [0065], the slide moves distally cause the guidewire to move distally simultaneously this distal movement of the slide and guidewire thus causes then the actuation of the catheter advancement assembly ([0065]).
With regard to claim 5, Blanchard discloses wherein the displacement of the catheter is less than the simultaneous displacement of the guidewire ([0065], distal movement of the guidewire is fully moved distally which causes the displacement of the catheter which can then be inserted and the catheter advancement assembly advances distally to a distance which may be smaller than the displacement of the guidewire).
With regard to claim 14, Blanchard discloses further including a safety assembly (54 and 56, better seen in Fig. 10a and 10b) configured to cover a distal tip of the needle upon withdrawal of the needle from the catheter (see Fig. 10a, [0058]), the safety assembly coupled between the catheter hub and the mechanical advantage mechanism ([0058]) such that distal displacement of the slide causes distal displacement of the safety assembly which in turn causes distal displacement of the catheter ([0058], [0066]).
With regard to claim 15, Blanchard discloses wherein: the slide (28) is configured to displace a first distance (slide moves along the outside of the housing and its initial distal movement can be considered a first distance and then a subsequent further movement to its distalmost end can be considered a second distance) and a subsequent second distance (further the claim language recites “configured to” and thus the device must only be capable of performing the reciting action), displacement of the slide the first distance causes the guidewire to distally displace a first guidewire distance with respect to the needle ([0065]), and displacement of the slide the subsequent second distance causes: the guidewire to distally displace a second guidewire distance with respect to the needle ([0065]), and the catheter to displace a first catheter distance with respect to the needle, the first catheter distance less than the second guidewire distance ([0065], distal movement of the guidewire is fully moved distally which causes the displacement of the catheter which can then be inserted and the catheter advancement assembly advances distally to a distance which may be smaller than the displacement of the guidewire).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard (US 2014/0094774 A1) in view of Drontle et al. (US 2010/0312101 A1) and in further view of Bogert (US 5,853,393).
With regard to claim 6 and 7, Blanchard/Drontle teaches the claimed invention except for a lever.
Bogert teaches a needle/catheter insertion mechanism (Fig. 1 and 2) including a helical mechanical advantage element (18, similar to Drontle) and further includes a lever (26) as part of the mechanical advantage mechanism that locks the helical mechanism in place prior to use. Bogert further teaches the lever includes an opening (24) and the needle (22) passes through the opening (see Fig. 1).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Blanchard/Drontle with the lever as taught by Bogert for the purpose of locking the catheter hub and needle prior to use to prevent premature use of the device (Col 5, lines 51 to end).
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783