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
The amendment filed on 6/4/2026 has been entered. Claims 1-7, 9-15, and 17-20 are pending in the application. Claims 8, 16, and 21 are cancelled. The amendments to the claims overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed on 2/4/2026.
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 1-5, 7, 9-13, 15, 17-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Boezaart (US 2010/0087755 A1) in view of Belson (US 8,690,833 B2).
Regarding claim 1, Boezaart discloses a medical device (medical insertion tool 10, see Fig. 1A) that is controllable with a hand of a user in which the medical device is held to deploy a catheter (catheter 42) in a body of a patient (see par. [0026], [0052]), the medical device comprising:
a housing (housing 11), the housing (housing 11) having a catheter holder (cartridge 15) that is configured to hold the catheter (catheter 42) (see Fig. 1A, par. [0057]), the housing (housing 11) having a first opening formed in a forward end of the housing (housing 11) through which a distal end of the catheter (catheter 42) passes when the catheter (catheter 42) is being deployed (see Fig. 1A, par. [0033]-[0034]), the housing (housing 11) containing a catheter pathway along which the catheter (catheter 42) moves (see Fig. 1A), the catheter pathway extending between the first opening and the catheter holder (cartridge 15) within the housing (housing 11) (see Fig. 1A, par. [0033]-[0034], [0057]), the forward end of the housing (housing 11) being adapted to be removably coupled with a proximal end of a needle (needle 32) thereby aligning the needle (needle 32) with the catheter pathway (see Fig. 1A, par. [0027], [0033]-[0034]);
a catheter deployment and retrieval mechanism (see par. [0076]-[0078]) mechanically coupled with the housing (housing 11) and configured to operate in a catheter deployment mode and in a catheter retrieval mode (see par. [0076]-[0078]), wherein the catheter deployment and retrieval mechanism (see par. [0076]-[0078]) comprises a levered trigger that, in the catheter deployment mode, is controllable with a digit of the hand of the user to cause the catheter (catheter 42) to be fed out of the catheter holder (cartridge 15) and to move along the catheter pathway in a first direction (see par. [0076]-[0078]), and in the catheter retrieval mode, is controllable with the digit of the hand of the user to cause the catheter (catheter 42) to be retracted and to move along the catheter pathway in a second direction that is substantially opposite the first direction (see par. [0076]-[0078], the tool 10 has an introducer assembly 40 which can include a pawl and ratchet assembly having a levered trigger to insert and retract the catheter 42);
a first port (see generally at 70 in Fig. 1A) mechanically coupled to, or integrally formed in, the housing (housing 11), the first port (see generally at 70 in Fig. 1A) being adapted to introduce a fluid into the housing (housing 11) (see Fig. 1A, par. [0058]), the fluid directed toward the proximal end of the needle (needle 32) (see Fig. 1A, par. [0026], [0058]).
However, Boezaart fails to expressly teach a diaphragm that acts as a one-way valve to allow the fluid introduced into the housing by the first port to flow in a first flow direction toward the proximal end of the needle while preventing the fluid from flowing in the second flow direction, and wherein the diaphragm allows the catheter to move through the diaphragm in the first direction and the second direction.
Belson teaches a medical device (see Figs. 1-5) comprising a diaphragm (valve 110) that acts as a one-way valve to allow the fluid introduced into the housing (fitting 104) by the first port (fitting 108) to flow in a first flow direction toward the proximal end of the needle (tubing 102) while preventing the fluid from flowing in the second flow direction (see col. 5 lines 28-44, valve 110 can be a duckbill valve which is a one-way check valve), and wherein the diaphragm (valve 110) allows the catheter (needle 7) to move through the diaphragm (valve 110) in the first direction and the second direction (see Figs. 1- 5, col. 5 lines 28-44, needle 7 can pass through the valve 110).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical device of Boezaart to include a diaphragm, as taught by Belson, in order to facilitate the delivery of fluids into the patient and movement of the catheter in a sealed manner (see Belson col. 5 lines 28-44).
Regarding claim 2, modified Boezaart teaches the medical device of claim 1 substantially as claimed. Boezaart further teaches wherein the medical device (tool 10) comprises a handle (grip 18) extending from the housing (housing 11) adjacent to the levered trigger (see Fig. 1A, par. [0053]-[0056], [0076]-[0078]), the handle (grip 18) adapted to be gripped by the hand of the user (see par. [0052], [0056]), and wherein pulling the levered trigger (see par. [0076]-[0078]) toward the handle (grip 18) with the digit of the hand of the user operates the catheter deployment and retrieval mechanism (see par. [0076]-[0078]) in the catheter deployment mode and in the catheter retrieval mode (see par. [0076]-[0078], the tool 10 has an introducer assembly 40 which can include a pawl and ratchet assembly having a levered trigger to insert and retract the catheter 42; the lever can be switched between two positions such that the trigger can be actuated/pulled to extend the catheter 42 when the lever is in a first position and the trigger can be actuated/pulled to retract the catheter 42 when the lever is in a second position).
Regarding claim 3, modified Boezaart teaches the medical device of claim 2 substantially as claimed. Boezaart further teaches wherein the catheter deployment and retrieval mechanism (see par. [0076]-[0078]) includes a ratchet that can be switched between the catheter deployment mode and the catheter retrieval mode (see par. [0076]-[0078]), wherein when the ratchet is in the catheter deployment mode, pulling of the levered trigger causes the catheter (catheter 42) to move in the first direction along the catheter pathway (see par. [0076]-[0078], the tool 10 has an introducer assembly 40 which can include a pawl and ratchet assembly having a levered trigger to insert and retract the catheter 42; the lever can be switched between two positions such that the trigger can be actuated/pulled to extend the catheter 42 when the lever is in a first position and the trigger can be actuated/pulled to retract the catheter 42 when the lever is in a second position), and wherein when the ratchet is in the catheter retrieval mode, pulling of the levered trigger causes the catheter (catheter 42) to move in the second direction along the catheter pathway (see par. [0076]-[0078], the tool 10 has an introducer assembly 40 which can include a pawl and ratchet assembly having a levered trigger to insert and retract the catheter 42; the lever can be switched between two positions such that the trigger can be actuated/pulled to extend the catheter 42 when the lever is in a first position and the trigger can be actuated/pulled to retract the catheter 42 when the lever is in a second position).
Regarding claim 4, modified Boezaart teaches the medical device of claim 1 substantially as claimed. Boezaart further teaches wherein the medical device (tool 10) comprises a handle (grip 18) extending from the housing (housing 11) adjacent to the levered trigger (see Fig. 1A, par. [0053]-[0056], [0076]-[0078]), the handle (grip 18) adapted to be gripped by the hand of the user (see par. [0052], [0056]), and wherein pulling the levered trigger toward the handle (grip 18) with the digit of the hand of the user advances the catheter (catheter 42) in the first direction in the catheter deployment mode and pushing the levered trigger away from the handle (grip 18) with the digit retracts the catheter (catheter 42) in the second direction in the catheter retrieval mode (see par. [0076]-[0078], the tool 10 has an introducer assembly 40 which can include a pawl and ratchet assembly having a levered trigger to insert and retract the catheter 42; the levered trigger can be moved in a first direction to extend the catheter 42 and in a second, opposite direction to retract the catheter 42).
Regarding claim 5, modified Boezaart teaches the medical device of claim 1 substantially as claimed. Boezaart further teaches wherein the catheter holder (cartridge 15) comprises a cartridge (cartridge 15) that holds the catheter (catheter 42) in a coiled configuration (see Fig. 1A, catheter 42 is coiled within cartridge 15), the cartridge (cartridge 15) being removably secured to a cartridge- mounting surface (see Fig. 1B, walls around void space 17) of the housing (housing 11) and being engaged with the catheter deployment and retrieval mechanism (see par. [0056]-[0057], [0059]).
Regarding claim 7, modified Boezaart teaches the medical device of claim 1 substantially as claimed. Boezaart further teaches wherein the proximal end of the needle (needle 32) releasably locks to the forward end of the housing (housing 11) thereby aligning the needle (needle 32) with the catheter pathway (see Figs. 1A-B, par. [0032]-[0034]), wherein the proximal end of the needle (needle 32) decouples from the forward end of the housing (housing 11) when unlocked by at least one digit of the user, wherein the at least one digit of the user comprises the digit of the user, one or more other digit of the first hand or the second hand of the user, or a combination thereof (see par. [0032]).
Regarding claim 9, modified Boezaart teaches the medical device of claim 1 substantially as claimed. Boezaart further teaches a nerve stimulating wire (supplemental device 74) of an electrically-conductive material having a proximal end that is exposed to allow an electrical current to be applied to the proximal end of the nerve stimulating wire (supplemental device 74) and having a distal end that is electrically coupled to the catheter (catheter 42) (see Figs. 1A-C, par. [0028]-[0031], [0058]), wherein the nerve stimulating wire (supplemental device 74) extends outside the needle (needle 32) without entering the housing (housing 11) (see Fig. 1A).
Regarding claim 10, Boezaart discloses a catheter gun (medical insertion tool 10, see Fig. 1A) for deploying and retracting a catheter (catheter 42) (see par. [0026], [0052]), wherein the catheter gun (medical insertion tool 10) is controllable with a first hand of a user in which the catheter gun (medical insertion tool 10) is held while operating an ultrasound probe with a second hand of the user (see par. [0004], [0026], [0052], [0060]-[0061]), the catheter gun comprising:
a housing (housing 11), the housing (housing 11) having a catheter holder (cartridge 15) that is configured to hold the catheter (catheter 42) in a coiled configuration (see Fig. 1A, par. [0057], catheter 42 is coiled within cartridge 15), the catheter holder (cartridge 15) being within the housing (housing 11) and engaged with a catheter deployment and retrieval mechanism (see par. [0026], [0052], [0076]-[0078]), the housing (housing 11) having a first opening formed in a forward end of the housing (housing 11) through which a distal end of the catheter (catheter 42) passes when the catheter (catheter 42) is being deployed (see Fig. 1A, par. [0033]-[0034]), the housing (housing 11) containing a catheter pathway along which the catheter (catheter 42) moves (see Fig. 1A) that extends between the first opening and the catheter holder (cartridge 15) within the housing (housing 11) (see Fig. 1A, par. [0033]-[0034], [0057]), the forward end being adapted to be removably coupled with a proximal end of a needle (needle 32) thereby aligning the needle (needle 32) with the catheter pathway (see Fig. 1A, par. [0027], [0033]-[0034]), the housing (housing 11) having a handle (grip 18) extending from the housing (housing 11) that is adapted to be gripped by the user (see Fig. 1A, par. [0053]-[0056]);
the catheter deployment and retrieval mechanism (see par. [0076]-[0078]) being configured to operate in a catheter deployment mode and in a catheter retrieval mode (see par. [0076]-[0078]), wherein the catheter deployment and retrieval mechanism (see par. [0076]-[0078]) comprises a levered trigger that when the user grips the handle (grip 18) with the first hand, a digit of the first hand can reach the levered trigger (see par. [0053]-[0056], [0076]-[0078]), wherein in the catheter deployment mode, the levered trigger is controllable with the digit of the first hand to cause the catheter (catheter 42) to be fed out of the catheter holder (cartridge 15) and to move along the catheter pathway in a first direction (see par. [0076]-[0078]) as the user operates the ultrasound probe with the second hand (see par. [0060]-[0061]), and wherein in the catheter retrieval mode, the levered trigger is controllable with the digit of the first hand to cause the catheter (catheter 42) to be retracted and to move along the catheter pathway in a second direction (see par. [0076]-[0078], the tool 10 has an introducer assembly 40 which can include a pawl and ratchet assembly having a levered trigger to insert and retract the catheter 42) as the user operates the ultrasound probe with the second hand (see par. [0060]-[0061]), the first direction being substantially opposite the second direction (see par. [0076]-[0078]);
a first port (see generally at 70 in Fig. 1A) mechanically coupled to, or integrally formed in, the housing (housing 11), the first port (see generally at 70 in Fig. 1A) being adapted to introduce a fluid into the housing (housing 11) (see Fig. 1A, par. [0058]), the fluid directed toward the proximal end of the needle (needle 32) (see Fig. 1A, par. [0026], [0058]).
However, Boezaart fails to expressly teach a diaphragm that acts as a one-way valve to allow the fluid introduced into the housing by the first port to flow in a first flow direction toward the proximal end of the needle while preventing the fluid from flowing in a second flow direction that is opposite the first flow direction.
Belson teaches a catheter gun (see Figs. 1-5) comprising a diaphragm (valve 110) that acts as a one-way valve to allow the fluid introduced into the housing (fitting 104) by the first port (fitting 108) to flow in a first flow direction toward the proximal end of the needle (tubing 102) while preventing the fluid from flowing in a second flow direction that is opposite the first flow direction (see Figs. 1-5, col. 5 lines 28-44, valve 110 can be a duckbill valve which is a one-way check valve).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter gun of Boezaart to include a diaphragm, as taught by Belson, in order to facilitate the delivery of fluids into the patient and movement of the catheter in a sealed manner (see Belson col. 5 lines 28-44).
Regarding claim 11, modified Boezaart teaches the catheter gun of claim 10 substantially as claimed. Boezaart further teaches wherein the catheter deployment and retrieval mechanism (see par. [0076]-[0078]) includes a ratchet that can be switched between the catheter deployment mode and the catheter retrieval mode (see par. [0076]-[0078]), wherein when the ratchet is in the catheter deployment mode, pulling of the levered trigger with the digit of the first hand causes the catheter (catheter 42) to move in the first direction along the catheter pathway (see par. [0076]-[0078], the tool 10 has an introducer assembly 40 which can include a pawl and ratchet assembly having a levered trigger to insert and retract the catheter 42; the lever can be switched between two positions such that the trigger can be actuated/pulled to extend the catheter 42 when the lever is in a first position and the trigger can be actuated/pulled to retract the catheter 42 when the lever is in a second position), and wherein when the ratchet is in the catheter retrieval mode, pulling of the levered trigger with the digit of the first hand causes the catheter (catheter 42) to move in the second direction along the catheter pathway (see par. [0076]-[0078], the tool 10 has an introducer assembly 40 which can include a pawl and ratchet assembly having a levered trigger to insert and retract the catheter 42; the lever can be switched between two positions such that the trigger can be actuated/pulled to extend the catheter 42 when the lever is in a first position and the trigger can be actuated/pulled to retract the catheter 42 when the lever is in a second position).
Regarding claim 12, modified Boezaart teaches the catheter gun of claim 10 substantially as claimed. Boezaart further teaches wherein pulling the levered trigger with the digit of the first hand toward the handle (grip 18) advances the catheter (catheter 42) in the first direction in the catheter deployment mode and pushing the levered trigger away from the handle (grip 18) retracts the catheter (catheter 42) in the second direction in the catheter retrieval mode (see par. [0076]-[0078], the tool 10 has an introducer assembly 40 which can include a pawl and ratchet assembly having a levered trigger to insert and retract the catheter 42; the levered trigger can be moved in a first direction to extend the catheter 42 and in a second, opposite direction to retract the catheter 42).
Regarding claim 13, modified Boezaart teaches the catheter gun of claim 10 substantially as claimed. Boezaart further teaches wherein the catheter holder (cartridge 15) is a cartridge (cartridge 15) that is removably secured to a cartridge-mounting surface (see Fig. 1B, walls around void space 17) of the housing (housing 11) and engaged with the catheter deployment and retrieval mechanism (see par. [0056]-[0057], [0059]).
Regarding claim 15, modified Boezaart teaches the catheter gun of claim 11 substantially as claimed. Boezaart further teaches wherein the proximal end of the needle (needle 32) releasably locks to the forward end of the housing (housing 11) thereby aligning the needle (needle 32) with the catheter pathway (see Figs. 1A-B, par. [0032]-[0034]), wherein the proximal end of the needle (needle 32) decouples from the forward end of the housing (housing 11) when unlocked by at least one digit of the user, wherein the one or more digit of the user comprises the digit of the user, one or more other digit of the first hand or the second hand of the user, or a combination thereof (see par. [0032]).
Regarding claim 17, modified Boezaart teaches the catheter gun of claim 10 substantially as claimed. Boezaart further teaches a nerve stimulating wire (supplemental device 74) of an electrically-conductive material having a proximal end that is exposed to allow an electrical current to be applied to the proximal end of the nerve stimulating wire (supplemental device 74) and having a distal end that is electrically coupled to the catheter (catheter 42) (see Figs. 1A-C, par. [0028]-[0031], [0058]), wherein the nerve stimulating wire (supplemental device 74) extends outside the needle (needle 32) without entering the housing (housing 11) (see Fig. 1A).
Regarding claim 18, Boezaart discloses a method for controlling a medical device (medical insertion tool 10, see Fig. 1A) with a hand of a user to deploy a catheter (catheter 42) in a body of a patient (see par. [0026], [0052]), the method comprising:
with the hand of the user, moving the medical device (tool 10) to cause a distal end of a needle (needle 32) to be inserted into a first location of the body (see par. [0060]), wherein a proximal end of the needle (needle 32) is mechanically coupled to a forward end of the medical device (tool 10) (see Fig. 1A, par. [0027], [0033]-[0034]), the medical device (tool 10) comprising:
a housing (housing 11) having a catheter holder (cartridge 15) that is configured to hold the catheter (catheter 42) (see Fig. 1A, par. [0057]), the housing (housing 11) having a first opening formed in a forward end of the housing (housing 11) through which a distal end of the catheter (catheter 42) passes when the catheter (catheter 42) is being deployed (see Fig. 1A, par. [0033]-[0034]), the housing (housing 11) containing a catheter pathway along which the catheter (catheter 42) moves (see Fig. 1A) that extends between the first opening and the catheter holder (cartridge 15) within the housing (housing 11) (see Fig. 1A, par. [0033]-[0034], [0057]), the forward end of the housing (housing 11) being adapted to be removably coupled with the proximal end of the needle (needle 32) thereby aligning the needle (needle 32) with the catheter pathway (see Fig. 1A, par. [0027], [0033]-[0034]);
a catheter deployment and retrieval mechanism (see par. [0076]-[0078]) mechanically coupled with the housing (housing 11) and configured to operate in a catheter deployment mode and in a catheter retrieval mode (see par. [0076]-[0078]), wherein the catheter deployment and retrieval mechanism (see par. [0076]-[0078]) comprises a levered trigger that, in the catheter deployment mode, is controllable with a digit of the hand of the user to cause the catheter (catheter 42) to be fed out of the catheter holder (cartridge 15) and to move along the catheter pathway in a first direction (see par. [0076]-[0078]), and in the catheter retrieval mode, is controllable with the digit of the hand of the user to cause the catheter (catheter 42) to be retracted and to move along the catheter pathway in a second direction that is substantially opposite the first direction (see par. [0076]-[0078], the tool 10 has an introducer assembly 40 which can include a pawl and ratchet assembly having a levered trigger to insert and retract the catheter 42);
a first port (see generally at 70 in Fig. 1A) mechanically coupled to, or integrally formed in, the housing (housing 11), the first port (see generally at 70 in Fig. 1A) being adapted to introduce a fluid into the housing (housing 11) (see Fig. 1A, par. [0058]), the fluid directed toward the proximal end of the needle (needle 32) (see Fig. 1A, par. [0026], [0058]);
with the digit of the hand of the user, placing the catheter deployment and retrieval mechanism (see par. [0076]-[0078]) of the medical device (tool 10) in the catheter deployment mode (see par. [0052], [0056], [0063]-[0064], [0076]-[0078]), the catheter (catheter 42) being held in a coiled configuration in the catheter holder (cartridge 15) (see Fig. 1A, catheter 42 is coiled within cartridge 15); and
with the digit of the hand of the user, operating the levered trigger of the catheter deployment and retrieval mechanism (see par. [0076]-[0078]) to cause the catheter (catheter 42) to be fed out of the catheter holder (cartridge 15) and to move along the catheter pathway in the first direction (see par. [0052], [0056], [0063]-[0064], [0076]- [0078]).
However, Boezaart fails to expressly teach that the medical device comprises a diaphragm that acts as a one-way valve to allow the fluid introduced into the housing by the first port to flow in a first flow direction toward the proximal end of the needle while preventing the fluid from flowing in a second flow direction, and wherein the diaphragm allows the catheter to move through the diaphragm in the first direction and the second direction.
Belson teaches a method for controlling a medical device (see Figs. 1-5), the medical device (see Figs. 1-5) comprising a diaphragm (valve 110) that acts as a one-way valve to allow the fluid introduced into the housing (fitting 104) by the first port (fitting 108) to flow in a first flow direction toward the proximal end of the needle (tubing 102) while preventing the fluid from flowing in a second flow direction (see col. 5 lines 28-44, valve 110 can be a duckbill valve which is a one-way check valve), and wherein the diaphragm (valve 110) allows the catheter (needle 7) to move through the diaphragm (valve 110) in the first direction and the second direction (see Figs. 1- 5, col. 5 lines 28-44, needle 7 can pass through the valve 110).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Boezaart to include that the medical device comprises a diaphragm, as taught by Belson, in order to facilitate the delivery of fluids into the patient and movement of the catheter in a sealed manner (see Belson col. 5 lines 28-44).
Regarding claim 20, modified Boezaart teaches the method of claim 18 substantially as claimed. Boezaart further teaches:
with one or more digit of the hand of the user, causing the catheter holder (cartridge 15) to be decoupled from the housing (housing 11) of the medical device (tool 10), wherein the one or more digit of the hand of the user comprises the digit of the hand of the user, one or more other digit of the hand of the user, or a combination thereof (see par. [0052]-[0057]); and
with at least one digit of the user, causing the proximal end of the needle (needle 32) to be decoupled from the forward end of the medical device (tool 10), wherein the at least one digit of the user comprises the digit of the user, at least one other digit of the first hand or a second hand of the user, or a combination thereof (see Figs. 1A-B, par. [0032]-[0034]).
Claims 6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Boezaart (US 2010/0087755 A1) in view of Belson (US 8,690,833 B2), as applied to claims 5 and 13 above, further in view of Chittenden (US 4,342,313 A).
Regarding claim 6, modified Boezaart teaches the medical device of claim 5 substantially as claimed. However, modified Boezaart fails to expressly state wherein the cartridge releasably locks to the cartridge-mounting surface with a friction grip placed on the catheter when the cartridge is locked to the cartridge-mounting surface, wherein the cartridge decouples from the housing and removes the friction grip when unlocked by one or more digit of the user, wherein the one or more digit of the user comprises the digit of the user, one or more other digit of the first hand or the second hand of the user, or a combination thereof.
Chittenden teaches a medical device (see Figs. 1-2) wherein the cartridge (catheter receptacle 10) releasably locks to the cartridge-mounting surface (wall 49) with a friction grip placed on the catheter (catheter 2) when the cartridge (catheter receptacle 10) is locked to the cartridge-mounting surface (wall 49), wherein the cartridge (catheter receptacle 10) decouples from the housing (see Figs. 1-2) and removes the friction grip when unlocked by one or more digit of the user, wherein the one or more digit of the user comprises the digit of the user, one or more other digit of the first hand or the second hand of the user, or a combination thereof (see col. 3 lines 42-62, col. 6 lines 24-36).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical device of modified Boezaart to include the releasable lock and friction grip, as taught by Chittenden, in order to provide the mechanisms for releasing and securing the cartridge to the medical device (see Chittenden col. 3 lines 42-62).
Regarding claim 14, modified Boezaart teaches the catheter gun of claim 13 substantially as claimed. However, modified Boezaart fails to expressly state wherein the cartridge releasably locks to the cartridge-mounting surface with a friction grip placed on the catheter when the cartridge is locked to the cartridge-mounting surface, wherein the cartridge decouples from the housing and removes the friction grip when unlocked by one or more digit of the user, wherein the one or more digit of the user comprises the digit of the user, one or more other digit of the first hand or the second hand of the user, or a combination thereof.
Chittenden teaches a catheter gun (see Figs. 1-2) wherein the cartridge (catheter receptacle 10) releasably locks to the cartridge-mounting surface (wall 49) with a friction grip placed on the catheter (catheter 2) when the cartridge (catheter receptacle 10) is locked to the cartridge-mounting surface (wall 49), wherein the cartridge (catheter receptacle 10) decouples from the housing (see Figs. 1-2) and removes the friction grip when unlocked by one or more digit of the user, wherein the one or more digit of the user comprises the digit of the user, one or more other digit of the first hand or the second hand of the user, or a combination thereof (see col. 3 lines 42-62, col. 6 lines 24-36).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter gun of modified Boezaart to include the releasable lock and friction grip, as taught by Chittenden, in order to provide the mechanisms for releasing and securing the cartridge to the medical device (see Chittenden col. 3 lines 42-62).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Boezaart (US 2010/0087755 A1) in view of Belson (US 8,690,833 B2), as applied to claim 18 above, further in view of Kaufman et al. (US 2003/0120267 A1).
Regarding claim 19, modified Boezaart teaches the method of claim 18 substantially as claimed. Boezaart further teaches: with the digit of the hand of the user, operating the levered trigger to cause the catheter (catheter 42) to be retracted toward the catheter holder (cartridge 15) and to move along the catheter pathway in the second direction that is substantially opposite to the first direction (see par. [0052], [0056], [0063]-[0064], [0076]-[0078]);
with the hand of the user, moving the medical device (tool 10) to cause the distal end of the needle (needle 32) to be removed from the first location of the body (see par. [0064]).
However, modified Boezaart fails to expressly state with the hand of the user, moving the medical device to cause the distal end of the needle to be inserted into a second location of the body; with the digit of the hand of the user, operating the levered trigger of the catheter deployment and retrieval mechanism to cause the catheter to be fed out of the catheter holder and to move along the catheter pathway in the first direction.
Kaufman teaches a method for controlling a medical device (see Figs. 1A, 2, and 6) comprising: with the hand of the user, moving the medical device (see Figs. 1A, 2, and 6) to cause the distal end of the needle (needle type sheath 1) to be removed from the first location of the body and to cause the distal end of the needle (needle type sheath 1) to be inserted into a second location of the body (see par. [0016], for repositioning); and with the digit of the hand of the user, causing the catheter (inner member 11) to be fed out of the medical device and to move along the catheter pathway in the first direction (see par. [0016], the needle/catheter are inserted into the patient, the catheter/needle are withdrawn, the needle is inserted into a second location of the patient, and the catheter is inserted through the needle again for repositioning the device).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Boezaart to include that the user moves the medical device to cause the distal end of the needle to be inserted into a second location of the body and with the digit of the hand of the user, causing the catheter to be fed out of the medical device and to move along the catheter pathway in the first direction, as taught by Kaufman, in order to allow for repositioning of the medical device in the patient (see Kaufman par. [0016]). Since the catheter (catheter 42) of Boezaart is fed out of the catheter holder (cartridge 15) in the first direction by operating the levered trigger (Boezaart par. [0076]-[0078]) of the catheter deployment and retrieval mechanism (Boezaart par. [0076]-[0078]), this modification teaches with the digit of the hand of the user, operating the levered trigger of the catheter deployment and retrieval mechanism to cause the catheter to be fed out of the catheter holder and to move along the catheter pathway in the first direction substantially as claimed.
Response to Arguments
Applicant's arguments filed 6/4/2026 have been fully considered but they are not persuasive.
In regards to independent claims 1, 10, and 18, Applicant argues that the first port of Boezaart does not direct fluid toward a proximal end of the needle. This argument is not found to be persuasive. The rejection identifies the first port as element 70 in Fig. 1A of Boezaart. Fig. 1A and paragraph [0058] describe that an irrigation device can be connected in this region. Paragraph [0026] further describes that fluid is discharged from the catheter 42. Thus, fluid enters the device through element 70 and discharges from the catheter 42. Since the needle 32 is along the flow path from element 70 through the distal end of the catheter 42, the fluid would be directed from element 70 toward the proximal end of needle 32. It is unclear whether Applicant intends for this limitation to require that the fluid flows directly through the needle, however this limitation is not recited in the claims.
Applicant further argues that Belson’s diaphragm does not teach the flow paths recited in claims 1, 10, and 18. This argument is not persuasive. As stated in the rejection above, Belson recites that the valve 110 can be a duckbill valve (see col. 5 lines 28-44). Duckbill valves are one-way valves which allow fluid to flow in one direction and prevent backflow in the reverse direction. Therefore, it would appear that such a valve added into the device of Boezaart would teach the recited functional limitations of the diaphragm in claims 1, 10, and 18.
In regards to dependent claims 9 and 17, Applicant argues that Boezaart’s cables 72 and 152 do not extend outside the needle without entering the housing, as recited in the amendment. This argument is not found to be persuasive. In light of this amendment, the Examiner considers the supplemental device 74 to correspond to the claimed nerve stimulating wire, as supplemental device 74 is electrically coupled to cable 72 (see Fig. 1A, par. [0058]). The entire supplemental device 74 extends outside of the needle 32 without entering the housing 11. Thus, this interpretation of Boezaart would still appear to read on the amendment to claim 9.
In regards to dependent claims 6 and 14, Applicant argues that Chittenden is silent as to a friction grip placed on the catheter. This argument is not found to be persuasive. Col. 3 lines 42-62 of Chittenden recite that “catheter receptacle 10 has an inwardly facing wall 12 for receiving catheter 2 therein and mechanically engaging same…catheter 2 is mechanically engaged with receptacle 10”. Thus, when the device is fully assembled and the cartridge is locked with catheter inside, the catheter includes a mechanically engaged “friction grip”. But when the cartridge is unlocked and the catheter device is disassembled, the mechanical engagement/“friction grip” is removed. Thus, the Examiner maintains that Chittenden reads on these limitations of claims 6 and 14.
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 AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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