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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 16 March 2026 has been entered.
Response to Amendment
Claims 1-12 and 14-21 are currently pending. Claims 1 and 14 have been amended. Claim 21 has been added. Claim 13 has been cancelled.
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, 9, and 14 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).
Regarding claim 1, Belson et al. ‘574 teaches a catheter system (Figs. 1-8 catheter insertion device 20 and [0014]), comprising:
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]; “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 guidewire advancement feature extending through the slot and movable along the slot (Fig. 1 dowel pin 10 and [0015]), wherein the guidewire advancement feature comprises a portion external to the slot and configured to be contacted by a user (Fig. 1 actuator handle 9 and [0017]), wherein the guidewire advancement feature further comprises another portion disposed within the housing and at least partially surrounding the tube disposed within the housing (Fig. 1 slider 4 and [0022]; “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 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 disposed at least partially 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]).
Belson et al. ‘574 teaches all of the elements of the current invention as mentioned above except for wherein the portion and the another portion are monolithically formed as a single unit and wherein the pinch member is a plurality of pinch members, the plurality of pinch members are configured to pinch the tube at the hub, proximal to the hub, or distal to the hub.
Burkholz et al. ‘245 teaches a first embodiment with a grip 115 with fingers 160 for a clinician to grab (Fig. 2 and [0063]) that are not monolithically formed and another embodiment where the grip 215 includes and arm 1010 that are monolithically-formed as a single piece (Fig. 10 and [0083]).
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 portion and the another portion of Belson et al. ‘574 to be monolithically formed as a single unit as Burkholz et al. ‘245 teaches that both embodiments would perform the same (actuated by a clinician or HCP to cause a device to be selectively advanced ([0051]).
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. 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 are configured to pinch the tube at the hub, proximal to the hub, or distal to the hub as Burkholz et al. ‘245 teaches that this will aid in compressing the air so that the air may escape via a vent.
Regarding claim 9, Belson et al. ‘574 teaches wherein the tube is transparent ([0023], [0015]).
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]), wherein the guidewire advancement feature comprises a portion external to the slot and configured to be contacted by a user (Fig. 1 actuator handle 9 and [0017]), wherein the guidewire advancement feature further comprises another portion disposed within the housing and at least partially surrounding the tube disposed within the housing (Fig. 1 slider 4 and [0022]; “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 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 portion and the another portion are monolithically formed as a single unit and wherein the pinch member is a plurality of pinch members, the plurality of pinch members is configured to pinch the tube at the hub, proximal to the hub, or distal to the hub.
Burkholz et al. ‘245 teaches a first embodiment with a grip 115 with fingers 160 for a clinician to grab (Fig. 2 and [0063]) that are not monolithically formed and another embodiment where the grip 215 includes and arm 1010 that are monolithically-formed as a single piece (Fig. 10 and [0083]).
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 portion and the another portion of Belson et al. ‘574 to be monolithically formed as a single unit as Burkholz et al. ‘245 teaches that both embodiments would perform the same (actuated by a clinician or HCP to cause a device to be selectively advanced ([0051]).
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. 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 prince member of Belson et al. ‘574 to include be a plurality of pinch members, the plurality of pinch members are configured to pinch the tube at the hub, proximal to the hub, or distal to the hub as Burkholz et al. ‘245 teaches that this will aid in compressing the air so that the air may escape via a vent.
Claims 2-4, 7, 8, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Belson et al. ‘574 in view of Burkholz et al. ‘245 further in view of Hentzler et al. ‘146 (US Pub No. 2022/0001146 – previously cited).
Regarding claim 2, 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.
Regarding claim 3, Belson et al. ‘574 in view of Burkholz et al. ‘245 further in view of Hentzler et al. ‘146 teaches all of the elements of the current invention as mentioned above except for wherein an inner diameter of the flash chamber is greater than an inner diameter of the tube.
Hentzler et al. ‘146 teaches a flash chamber 128 on a needle 120. Fig. 1B shows that the diameter of the flash chamber 128 is larger than the diameter of the needle 120.
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 flash chamber of Belson et al. ‘574 in view of Burkholz et al. ‘245 further in view of Hentzler et al. ‘146 to include having an inner diameter that is greater than an inner diameter of the tube as Hentzler et al. ‘146 teaches that this will aid in retaining blood and other fluids ([0020]).
Regarding claim 4, Belson et al. ‘574 in view of Burkholz et al. ‘245 further in view of Hentzler et al. ‘146 teaches al of the elements of the current invention as mentioned above except for wherein the flash chamber is non-removably coupled to the proximal end of 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]). There is no indication that the flash chamber 128 can be removed from needle 120, indicating that the flash chamber 128 is non-removable.
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 flash chamber of Belson et al. ‘574 in view of Burkholz et al. ‘245 further in view of Hentzler et al. ‘146 to include being non-removably coupled to the proximal end of the housing as Hentzler et al. ‘146 teaches that this will aid in retaining blood and other fluids.
Regarding claim 7, Belson et al. ‘574 in view of Burkholz et al. ‘245 further in view of Hentzler et al. ‘146 teaches all of the elements of the current invention as mentioned above except for a proximal end of the flash chamber comprises an air vent configured to pass air and not blood.
Hentzler et al. ‘146 teaches a plug 130 in the flash chamber 128 that comprises a venting material that allows gas (such as air) to pass through, but retains blood or other fluids within the flash chamber 128 to prevent passage of fluids through the flash chamber 128 (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 further in view of Hentzler et al. ‘146 to include a proximal end of the flash chamber comprises an air vent configured to pass air and not blood as Hentzler et al. ‘146 teaches that this will aid in preventing passage of fluids.
Regarding claim 8, Belson et al. ‘574 in view of Burkholz et al. ‘245 further in view of Hentzler et al. ‘146 teaches all of the elements of the current invention as mentioned above except for wherein a proximal end of the flash chamber is closed, wherein the flash chamber comprises an air vent distal to the proximal end of the flash chamber.
Hentzler et al. ‘146 teaches a plug 130 in the flash chamber 128 that comprises a venting material that allows gas (such as air) to pass through, but retains blood or other fluids within the flash chamber 128 to prevent passage of fluids through the flash chamber 128 (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 flash chamber of Belson et al. ‘574 in view of Burkholz et al. ‘245 further in view of Hentzler et al. ‘146 to include a closed proximal end, wherein the flash chamber comprises an air vent distal to the proximal end of the flash chamber as Hentzler et al. ‘146 teaches that this will aid in preventing passage of fluids.
Regarding claim 15, 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 wherein the catheter system further comprises 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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Belson et al. ‘574 in view of Burkholz et al. ‘245 further in view of Hentzler et al. ‘146.
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 portion and the another portion are monolithically formed as a single unit and wherein the pinch member is a plurality of pinch members, the plurality of pinch members is configured to pinch the tube at the hub, proximal to the hub, or distal to the hub.
Burkholz et al. ‘245 teaches a first embodiment with a grip 115 with fingers 160 for a clinician to grab (Fig. 2 and [0063]) that are not monolithically formed and another embodiment where the grip 215 includes and arm 1010 that are monolithically-formed as a single piece (Fig. 10 and [0083]).
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 portion and the another portion of Belson et al. ‘574 to be monolithically formed as a single unit as Burkholz et al. ‘245 teaches that both embodiments would perform the same (actuated by a clinician or HCP to cause a device to be selectively advanced ([0051]).
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. 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 prince member of Belson et al. ‘574 to include be a plurality of pinch members, the plurality of pinch members are configured to pinch the tube at the hub, proximal to the hub, or distal to the hub 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.
Response to Arguments
Applicant argues that the prior art does not teach the amendments to the claims. Upon further consideration, the Examiner has relied on different components of Belson et al. ‘574 and Burkholz et al. ‘245 to teach the independent claims. As such, Applicant’s arguments are considered moot.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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