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 .
Response to Amendment
Claims 14 and 16-27 are currently pending. Claims 1-12 have been cancelled. Claims 22-27 have been added.
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 14 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Belson et al. ‘574 (US Pub No. 2008/0300574 – previously cited) in view of Burkholz et al. ‘245 (US Pub No. 2021/0213245 – previously cited) further in view of Hentzler et al. ‘146 (US Pub No. 2022/0001146 – previously cited).
Regarding claim 14, Belson et al. ‘574 teaches a method of arterial catheterization (Title, Abstract), comprising:
inserting a catheter (Fig. 1 tubular intravenous catheter 13 and [0021]) of a catheter system (Figs. 1-8 catheter insertion device 20 and [0014]) into an artery ([0002], [0004]), wherein the catheter system comprises:
a catheter adapter (Fig. 1 front plug 2 and [0016]), comprising a distal end (Side where luer slip fitting 16 is.), a proximal end (Side where interlocking member 18 is.), and a catheter adapter lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter ([0027] states that the safety guidewire 11 is advanced through the lumen of the access needle 8 and support tubing 7, indicating that the front plug 2 includes a lumen for the guidewire 11 and access needle 8 to pass through.);
a catheter extending from the distal end of the catheter adapter (Fig. 1 tubular intravenous catheter 13 and [0021]);
a housing (Fig. 1 outer housing 1 and [0015]), comprising a distal end (Right side of housing 1.), a proximal end (Left side of housing 1.), and a slot disposed between the distal end of the housing and the proximal end of the housing (Fig. 1 slot 14 and [0015]);
an introducer needle (Fig. 1 access needle 8 and [0021]) comprising a sharp distal tip ([0021]; “tapered distal end”) and a proximal end (Left side of needle 8.), wherein the proximal end of the introducer needle is secured within the housing, wherein the introducer needle extends through the catheter (Fig. 2 and [0018]);
a tube disposed within the housing and in fluid communication with the proximal end of the introducer needle (Fig. 1 support tubing 7 and [0023]);
a guidewire advancement feature extending through the slot and movable along the slot (Fig. 1 dowel pin 10 and [0015]);
a guidewire comprising a distal end and a proximal end (Fig. 1 safety guidewire 11 and [0017]), wherein the proximal end of the guidewire is coupled to a hub (Fig. 1 sheath tubing 3 and [0023]) having a greater outer diameter than an outer diameter of the guidewire ([0023]; “The safety guidewire 11 extends through the internal lumen of a sheath tubing 3 and the proximal end of the safety guidewire 11 is attached at the proximal end of the sheath tubing 3.”), wherein the guidewire and the hub are disposed within the tube ([0022]; “The safety guidewire 11 extends through the internal lumen of a sheath tubing 3 and the proximal end of the safety guidewire 11 is attached at the proximal end of the sheath tubing 3…The support tubing 7 has a sliding fit inside the sheath tubing 3 so that the two parts telescope together as the slider 4 is advanced in the distal direction.”),
a pinch member, wherein the pinch member is at least partially disposed within the another portion of the guidewire advancement feature and move along an exterior of the tube with the guidewire advancement feature (Fig. 1 inner diameter of slider 4 and [0023]), thereby moving the hub distally and causing the guidewire to be advanced distally ([0027]); and
advancing the guidewire advancement feature along the slot from a proximal position to a distal position ([0017]).
Belson et al. ‘574 teaches all of the elements of the current invention as mentioned above except for wherein the pinch member is a plurality of pinch members, the plurality of pinch members pinching the tube, the plurality of pinch members move along an exterior of the tube, move the hub distally, and advance the guidewire through the introducer needle and beyond the sharp distal tip of the introducer needle.
Burkholz et al. ‘245 teaches a patency device 125 that includes a hub 165, interpreted as the claimed hub, this is within a second lumen 110. Ball bearings 170, interpreted as a plurality of pinch members, pinch the second lumen 110 and the hub 165. The translation direction of the grip 115, ball bearings 170, surface of the hub 165, and patency device 125 may be in the directions as depicted by bi-directional arrow 175. With the movement of the seal between the hub 165 and the ball bearings 170, air may be compressed within the second lumen 110 and the air may escape via the vent (Figs. 3, 4 and [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pinch member of Belson et al. ‘574 to be a plurality of pinch members, the plurality of pinch members pinching the tube, the plurality of pinch members move along an exterior of the tube, move the hub distally, and advance the guidewire through the introducer needle and beyond the sharp distal tip of the introducer needle as Burkholz et al. ‘245 teaches that this will aid in compressing the air so that the air may escape via a vent.
Belson et al. ‘574 in view of Burkholz et al. ‘245 teaches all of the elements of the current invention as mentioned above except for a flash chamber in fluid communication with a proximal end of the tube and extending proximal to the housing.
Hentzler et al. ‘146 teaches a flash chamber 128 positioned at a proximal end of a needle 120 to retain blood and other fluids (Fig. 1B and [0020]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter system of Belson et al. ‘574 in view of Burkholz et al. ‘245 to include a flash chamber in fluid communication with a proximal end of the tube and extending proximal to the housing at Hentzler et al. ‘146 teaches that this will aid in retaining blood and other fluids.
Belson et al. ‘574, as modified by Burkholz et al. ‘245 and Hentzler et al. ‘146 teaches receiving blood from the artery through the introducer needle ([0006] of Belson et al. ‘574) and directing the blood through the tube into the flash chamber (Fig. 1B and [0020] of Hentzler et al. ‘146), wherein the blood flows past the hub and through a portion of the tube pinched by the plurality of pinch members (Fig. 5 patency device 125 and [0051] of Burkholz et al. ‘245).
Regarding claim 21, Belson et al. ‘574 teaches a method of arterial catheterization (Title, Abstract), comprising:
inserting a catheter (Fig. 1 tubular intravenous catheter 13 and [0021]) of a catheter system (Figs. 1-8 catheter insertion device 20 and [0014]) into an artery ([0002], [0004]), wherein the catheter system comprises:
a catheter adapter (Fig. 1 front plug 2 and [0016]), comprising a distal end (Side where luer slip fitting 16 is.), a proximal end (Side where interlocking member 18 is.), and a catheter adapter lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter ([0027] states that the safety guidewire 11 is advanced through the lumen of the access needle 8 and support tubing 7, indicating that the front plug 2 includes a lumen for the guidewire 11 and access needle 8 to pass through.);
a catheter extending from the distal end of the catheter adapter (Fig. 1 tubular intravenous catheter 13 and [0021]);
a housing (Fig. 1 outer housing 1 and [0015]), comprising a distal end (Right side of housing 1.), a proximal end (Left side of housing 1.), and a slot disposed between the distal end of the housing and the proximal end of the housing (Fig. 1 slot 14 and [0015]);
an introducer needle (Fig. 1 access needle 8 and [0021]) comprising a sharp distal tip ([0021]; “tapered distal end”) and a proximal end (Left side of needle 8.), wherein the proximal end of the introducer needle is secured within the housing, wherein the introducer needle extends through the catheter (Fig. 2 and [0018]);
a tube disposed within the housing and in fluid communication with the proximal end of the introducer needle (Fig. 1 support tubing 7 and [0023]);
a guidewire advancement feature extending through the slot and movable along the slot (Fig. 1 dowel pin 10 and [0015]);
a guidewire comprising a distal end and a proximal end (Fig. 1 safety guidewire 11 and [0017]), wherein the proximal end of the guidewire is coupled to a hub (Fig. 1 sheath tubing 3 and [0023]) having a greater outer diameter than an outer diameter of the guidewire ([0023]; “The safety guidewire 11 extends through the internal lumen of a sheath tubing 3 and the proximal end of the safety guidewire 11 is attached at the proximal end of the sheath tubing 3.”), wherein the guidewire and the hub are disposed within the tube ([0022]; “The safety guidewire 11 extends through the internal lumen of a sheath tubing 3 and the proximal end of the safety guidewire 11 is attached at the proximal end of the sheath tubing 3…The support tubing 7 has a sliding fit inside the sheath tubing 3 so that the two parts telescope together as the slider 4 is advanced in the distal direction.”),
a pinch member, wherein the pinch member is at least partially disposed within the another portion of the guidewire advancement feature and move along an exterior of the tube with the guidewire advancement feature (Fig. 1 inner diameter of slider 4 and [0023]), thereby moving the hub distally and causing the guidewire to be advanced distally ([0027]); and
advancing the guidewire advancement feature along the slot from a proximal position to a distal position such that the guidewire moves distally beyond the sharp distal tip of the introducer needle ([0017]).
Belson et al. ‘574 teaches all of the elements of the current invention as mentioned above except for wherein the pinch member is a plurality of pinch members disposed within the guidewire advancement feature, wherein the plurality of pinch members is configured to pinch the tube and are configured to move along an exterior of the tube with the guidewire advancement feature to move the hub distally and advance the guidewire distally through the introducer needle and beyond the sharp distal tip of the introducer needle.
Burkholz et al. ‘245 teaches a patency device 125 that includes a hub 165, interpreted as the claimed hub, this is within a second lumen 110. Ball bearings 170, interpreted as a plurality of pinch members, pinch the second lumen 110 and the hub 165. The translation direction of the grip 115, ball bearings 170, surface of the hub 165, and patency device 125 may be in the directions as depicted by bi-directional arrow 175. With the movement of the seal between the hub 165 and the ball bearings 170, air may be compressed within the second lumen 110 and the air may escape via the vent (Figs. 3, 4 and [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pinch member of Belson et al. ‘574 to be a plurality of pinch members, the plurality of pinch members pinching the tube, the plurality of pinch members move along an exterior of the tube, move the hub distally, and advance the guidewire through the introducer needle and beyond the sharp distal tip of the introducer needle as Burkholz et al. ‘245 teaches that this will aid in compressing the air so that the air may escape via a vent.
Belson et al. ‘574 in view of Burkholz et al. ‘245 teaches all of the elements of the current invention as mentioned above except for a flash chamber disposed at a proximal end of the tube and extending proximal to the housing.
Hentzler et al. ‘146 teaches a flash chamber 128 positioned at a proximal end of a needle 120 to retain blood and other fluids (Fig. 1B and [0020]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter system of Belson et al. ‘574 in view of Burkholz et al. ‘245 to include a flash chamber disposed at a proximal end of the tube and extending proximal to the housing at Hentzler et al. ‘146 teaches that this will aid in retaining blood and other fluids.
Belson et al. ‘574, as modified by Burkholz et al. ‘245 and Hentzler et al. ‘146 teaches wherein the tube defines a blood-flow pathway extending from the proximal end of the introducer needle ([0006] of Belson et al. ‘574) to the flash chamber (Fig. 1B and [0020] of Hentzler et al. ‘146), wherein the blood flows past the hub and through a portion of the tube pinched by the plurality of pinch members (Fig. 5 patency device 125 and [0051] of Burkholz et al. ‘245).
Response to Arguments
Applicant argues that Belson et al. ‘574 does not teach the pinch members. The Examiner agrees however, Burkholz et al. ‘245 teaches this deficiency. Applicant also argues that Belson et al. ‘574 does not teach the blood-flow pathway. However, one of ordinary skill would understand that after combining the prior art, Belson et al. ‘574, Burkholz et al. ‘245, and Hentzler et al. ‘146, the blood would flow from the proximal end of the guidewire, past the pinch members, and to the flash chamber. As such, Applicant’s arguments are not persuasive and the 35 U.S.C. 103 rejections have been maintained.
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 AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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