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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/29/2025 has been entered.
Response to Amendment
The amendment filed on 9/29/2025 has been entered. Claims 1-20 are pending in the application. Claim 21 is cancelled. The amendments to the claims overcome each and every objection and most of the 112(b) rejections previously set forth in the Final Office Action mailed on 5/28/2025. Any 112(b) rejection which has not been overcome has been included again in this Office Action below.
Claim Objections
Claims 8, 14, and 20 are objected to because of the following informalities:
-Claim 8, line 7: please correct “the second flow direction” to “a second flow direction”
-Claim 8, lines 8-9: please correct “the first and second directions” to “the first direction and the second direction”
-Claim 14, line 4: please correct “the medical device” to “the housing”
-Claim 14, line 6: please correct “a second hand” to “the second hand”
-Claim 20, line 4: please correct “the digit of the user” to “the digit of the hand of the user”
-Claim 20, lines 4-5: please correct “one or more other digit of the us or more other digit of the first hand or a second hand of the user er” to “one or more other digits of the hand of the user or of a second hand of the user”
-Claim 20, line 8: please correct “the digit of the user” to “the digit of the hand of the user”
-Claim 20, lines 8-9: please correct “at least one other digit of the first hand or a second hand of the user” to “at least one other digit of the hand of the user or of the second hand of the user”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-7 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation “when unlocked by one or more digit of the user” in lines 4-5. It is unclear whether the “one or more digit of the user” includes the digit of the hand of the user previously recited in claim 1. It is further unclear whether the “one or more digit of the user” should be limited to additional digit(s) of the same hand previously recited or whether this would include additional digit(s) of the user’s other hand. For examination purposes, the Examiner interprets “one or more digit of the user” as “the digit of the hand of the user or one or more additional digits of the hand of the user or of a second hand of the user” which means that the cartridge can be unlocked by any of the user’s digits on either hand.
Claim 7 is rejected by virtue of its dependency on rejected claim 6.
Claim 7 recites “when unlocked by at least one digit of the user”. It is unclear whether the “at least one digit of the user” includes the digit of the hand of the user previously recited in claim 1. It is further unclear whether the “at least one digit of the user” should be limited to additional digit(s) of the same hand previously recited or whether this would include additional digit(s) of the user’s second hand. It is further unclear whether the digit(s) which unlocks the cartridge per claim 6 (which can also be any of the user’s digits on either hand) must be the same digit(s) which unlocks the needle per claim 7. For examination purposes, the Examiner interprets that the digit(s) which unlock the needle can be any digit(s) on either hand of the user and that the digit(s) which unlock the needle is not required to be the same digit(s) which unlock the cartridge.
Claim 15 recites the limitation “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 a second hand of the user, or a combination thereof”. Thus, it appears that the needle can be decoupled by any of the user’s digits on either hand. However, claim 14 recites a similar limitation and it is unclear whether the digit which unlocks the cartridge (which can also be any of the user’s digits on either hand) must be the same digit which unlocks the needle. For examination purposes, the Examiner interprets that the digit(s) which unlock the needle are not required to be the same digit(s) which unlock the cartridge.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 9-13, 17-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boezaart (US 2010/0087755 A1).
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]); and
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).
Regarding claim 2, Boezaart discloses the medical device of claim 1, 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, Boezaart discloses the medical device of claim 2, 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, Boezaart discloses the medical device of claim 1, 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, Boezaart discloses the medical device of claim 1, 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 9, Boezaart discloses the medical device of claim 1, further comprising: a nerve stimulating wire (cable 72 or 152) 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 (cable 72 or 152) and having a distal end that is electrically coupled to the catheter (catheter 42) (see Figs. 1A-C, par. [0028]-[0031], [0058]).
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]); and
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]).
Regarding claim 11, Boezaart discloses the catheter gun of claim 10, 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, Boezaart discloses the catheter gun of claim 10, 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, Boezaart discloses the catheter gun of claim 10, 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 17, Boezaart discloses the catheter gun of claim 10, further comprising: a nerve stimulating wire (cable 72 or 152) 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 (cable 72 or 152) and having a distal end that is electrically coupled to the catheter (catheter 42) (see Figs. 1A-C, par. [0028]-[0031], [0058]).
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]); and
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);
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]).
Regarding claim 20, Boezaart discloses the method of claim 18, further comprising: with one or more digit 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 user comprises the digit of the user, one or more other digit of the us one or more other digit of the first hand or a second 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]).
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.
Claims 6-7 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Boezaart (US 2010/0087755 A1), as applied to claims 5 and 13 above, in view of Chittenden (US 4,342,313 A).
Regarding claim 6, Boezaart discloses the medical device of claim 5. However, 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 medical device and removes the friction grip when unlocked by one or more digit of the user.
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 medical device (see Figs. 1-2) and removes the friction grip when unlocked by one or more digit of the user (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 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 7, modified Boezaart teaches the medical device of claim 6 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 (see par. [0032]).
Regarding claim 14, Boezaart discloses the catheter gun of claim 13. However, 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 medical device 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 a 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 medical device (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 a 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 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 15, modified Boezaart teaches the catheter gun of claim 14 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 a second hand of the user, or a combination thereof (see par. [0032]).
Claims 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Boezaart (US 2010/0087755 A1), as applied to claims 1 and 10 above, in view of Belson (US 8,690,833 B2).
Regarding claim 8, Boezaart discloses the medical device of claim 1, further comprising: 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 and second directions.
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 and second directions (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 16, Boezaart discloses the catheter gun of claim 10, further comprising: 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 through 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 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).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Boezaart (US 2010/0087755 A1), as applied to claim 18 above, in view of Kaufman et al. (US 2003/0120267 A1).
Regarding claim 19, Boezaart discloses the method of claim 18, further comprising: 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, 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 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 with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
The Examiner has determined that a few of the secondary references which were previously cited still apply to some of the rejections of the amended dependent claims in this Office Action. Thus, the Examiner will respond to any arguments which may still apply below.
Regarding the Chittenden reference, Applicant argues (see Remarks pages 21-22) that Chittenden is silent as to “the cartridge releasably locks to the cartridge-mounting surface with a friction grip placed on the catheter” as recited in claim 6. This argument is not found persuasive. The broadest reasonable interpretation of “a friction grip” in this context is that the catheter is directly contacted by a structure when the cartridge is locked to the cartridge-mounting surface. In col. 3 lines 42-62 of Chittenden, it is described that when the catheter receptacle 10 is locked to base 6, catheter 2 is mechanically engaged with catheter receptacle 10. This teaches the limitation substantially as recited in the claim.
Conclusion
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783