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 3/30/2026 has been entered. Claims 1-13 and 15-21 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 1/12/2026.
Claim Objections
Claims 12 and 20 are objected to because of the following informalities:
Claim 12 recites the limitation “the biliary” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation “the biliary” in last line. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
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 1-7, 11, 13, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kushner (US 2009/0270835 A1) in view of Miyagi et al. (US 5,438,975) and further in view of Mirzalou et al. (US 2019/0175875 A1).
Regarding claim 1, Kushner discloses a system (figure 1) for treating a stricture, the system comprising:
a handle 12 having a base (see “B” in figure 1 below) having a proximal end region (region of element 12 comprising element “B” in figure 1 below and element 16);
a length adjustment member 21 coupled to the handle 12, the length adjustment member 12 having a distal end (end of element 21 connected to element 25) configured to be attached to an endoscope (instead of element 25, endoscope could be attached);
wherein the base (see “B” in figure 1 below) is movable relative to the length adjustment member 21 (paragraph 0044, lines 8-11);
a length actuator 32 (one can hold element 32 to move element 21) coupled to the handle 12, the length actuator 32 being configured to allow a user to vary a position of the base relative to the length adjustment member (paragraph 0044, lines 8-11);
a catheter shaft 26 coupled to the base;
a steering mechanism (mechanism formed by elements 22, 39, 38, 40) coupled to the handle 12, the steering mechanism (mechanism formed by elements 22, 39, 38, 40) being configured to steer the catheter shaft 26; and
wherein the steering mechanism (mechanism formed by elements 22, 39, 38, 40) includes an elongate steering member 38 having a first end region (region of element 38 coupled to element 39) coupled to the handle 12, a first body region (region of element 38 extending from element 39 to 40) extending along the catheter shaft 26 but is silent regarding a loop region surrounding a peripheral surface of the catheter shaft, a second body region extending along the catheter shaft, and a second end region coupled to the handle.
However, Miyagi teaches a design of a steerable mechanism (figure 3) comprising a loop region 1a (figure 1) extending about the catheter shaft (when connected to element 3, element 2 would be surrounding a peripheral surface of element 3 which is a distal part of entire catheter shaft/tubular shaft comprising element 4 not completely shown in figures), a second body region (another portion of wire 1 extending from element 2) extending along the catheter shaft (another portion of wire 1 extending from element 2 is extending into element 4), and a second end region (end of another portion of wire 1 extending from element 2 coupled to proximal end of the endoscope, column 4, lines 40-44) coupled to the endoscope for the purpose of firmly holding the steering member to distal tip of the catheter shaft under a strong tension or stress (column 9, lines 46-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the steering mechanism of Kushner to incorporate a loop region surrounding a peripheral surface of the catheter shaft, a second body region extending along the catheter shaft, and a second end region coupled to the proximal end as taught by Miyagi for the purpose of firmly holding the steering member to distal tip of the catheter shaft under a strong tension or stress (column 9, lines 46-50).
Kushner in view of Miyagi is silent regarding a second end region coupled to the handle but one of ordinary skill in the art, when modifying Kushner in view of Miyagi will couple a second end region to the handle because Kushner already teaches connecting an end region of the steering member to the handle.
Furthermore, Mirzalou teaches a design of a steerable catheter (figure 1) comprising a second end region (end of one of elements 240a, 240b, 230a, 230b as a second body region) coupled to the handle (paragraph 0021, lines 3-6) for the purpose of controlling the deflection of the catheter in the desired direction by operating appropriate steering member (paragraph 0022).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the connection of a second end region of Kushner/Miyagi to incorporate a second end region coupled to the handle as taught by Mirzalou for the purpose of controlling the deflection of the catheter in the desired direction by operating appropriate steering member (paragraph 0022).
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Regarding claim 2, Kushner discloses wherein the elongate steering member includes a steering wire 38.
Regarding claim 3, Kushner discloses wherein the elongate steering member includes a steering cable 38 but is silent regarding a steering wire being a multi-filar steering cable.
However, Mirzalou teaches wherein the elongate steering member includes a multi-filar steering cable (paragraph 0020, lines 9-14) for the purpose of designing the elongate steering member with sufficient tensile strength to articulate distal end of the catheter (paragraph 0020, lines 9-14).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the elongate steering member of Kushner to incorporate a multi-filar steering cable as taught by Mirzalou for the purpose of designing the elongate steering member with sufficient tensile strength to articulate distal end of the catheter (paragraph 0020, lines 9-14).
Regarding claim 4, Kushner is silent regarding wherein the first body region and the second body region extend adjacent to one another along the catheter shaft.
However, Mirzalou teaches wherein the first body region (either one of 240a or 240b or 230a or 230b) and the second body region (other of either 240a, 240b or 230a, 230b corresponding to chosen first body region for instance if 230a is selected as the first body region then 230b corresponds to second body region) extend adjacent to one another along the catheter shaft 120 for the purpose of controlling the steering of the catheter shaft in the desired direction (paragraph 0018).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the system of Kushner to incorporate wherein the first body region and the second body region extend adjacent to one another along the catheter shaft as taught by Mirzalou for the purpose of controlling the steering of the catheter shaft in the desired direction (paragraph 0018).
Regarding claim 5, Kushner discloses wherein the first body region, the second body region (region of element 38 extending from element 39 to 40), or both extend along an external surface of the catheter shaft 26.
Regarding claim 6, Kushner is silent regarding wherein the first body region, the second body region or both extend through a wall of the catheter shaft.
However, Mirzalou teaches wherein the first body region (either one of 240a or 240b or 230a or 230b), the second body region (other of either 240a, 240b or 230a, 230b corresponding to chosen first body region for instance if 230a is selected as the first body region then 230b corresponds to second body region) or both extend through a wall of the catheter shaft 120 for the purpose of controlling the steering of the catheter shaft in the desired direction (paragraph 0018).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the system of Kushner to incorporate wherein the first body region, the second body region or both extend through a wall of the catheter shaft as taught by Mirzalou for the purpose of controlling the steering of the catheter shaft in the desired direction (paragraph 0018).
Regarding claim 7, Kushner teaches wherein the first end region (end of element 38 connected to element 39) is coupled to a steering connector 39 disposed within the handle 12.
Kushner is silent regarding the second end region and therefore is silent regarding the second end region coupled to a steering connector disposed within the handle.
However, Mirzalou teaches wherein the second end region (end of selected elements 240a, 240b, 230a, 230b as a second body region) coupled to a steering connector (connector enabling connection with element 125) disposed (paragraph 0021, lines 3-6) within the handle 110 for the purpose of controlling the steering of the catheter shaft in the desired direction (paragraph 0018).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the system of Kushner to incorporate the second end region coupled to a steering connector disposed within the handle as taught by Mirzalou for the purpose of controlling the steering of the catheter shaft in the desired direction (paragraph 0018).
Regarding claim 11, Kushner discloses further comprising a needle attachment member (member/portion of element 20 connected or enabling connection with element 18) releasably coupled to the proximal end region (region of element 12 comprising element “B” in figure 1 above and element 16) of the handle.
Regarding claim 13, Kushner is silent regarding wherein the catheter shaft includes a first channel having a first body region extending therethrough and a second channel having the second body region extending therethrough.
However, Mirzalou teaches wherein the catheter shaft 120 includes a first channel 250 having a first body region (either one of 240a or 240b or 230a or 230b) extending therethrough and a second channel 250 having the second body region (other of either one of 240a or 240b or 230a or 230b) extending therethrough for the purpose of controlling the steering of the catheter shaft in the desired direction (paragraph 0018).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the catheter shaft of Kushner to incorporate wherein the catheter shaft includes a first channel having a first body region extending therethrough and a second channel having the second body region extending therethrough as taught by Mirzalou for the purpose of controlling the steering of the catheter shaft in the desired direction (paragraph 0018).
Regarding claim 16, Kushner discloses an endoscopic medical device (figure 1), comprising:
a length adjustment member 21,
a handle 12 coupled to the length adjustment member 21 and being movable relative to the length adjustment member 21 (paragraph 0044, lines 8-11);
a length actuator 32 (one can hold element 32 to move element 21) coupled to the handle 12, the length actuator 32 being configured to allow a user to vary a position of the handle relative to the length adjustment member 21 (paragraph 0044, lines 8-11);
a catheter shaft 26 coupled to the handle;
a steering actuator 22 coupled to the handle 12, the steering actuator being configured to steer the catheter shaft 26; and an elongate steering member 38 coupled to the steering actuator 22, the steering member 38 having a first end region (region of element 38 coupled to element 39) coupled to the handle 12, a first body region (region of element 38 extending from element 39 to 40) extending along the catheter shaft 26 but is silent regarding a loop region surrounding a peripheral surface of the catheter shaft, a second body region extending along the catheter shaft, and a second end region coupled to the handle.
However, Miyagi teaches a design of a steerable mechanism (figure 3) comprising a loop region 1a (figure 1) extending about the catheter shaft (when connected to element 3, element 2 would be surrounding a peripheral surface of element 3 which is a distal part of entire catheter shaft/tubular shaft comprising element 4 not completely shown in figures), a second body region (another portion of wire 1 extending from element 2) extending along the catheter shaft (another portion of wire 1 extending from element 2 is extending into element 4), and a second end region (end of another portion of wire 1 extending from element 2 coupled to proximal end of the endoscope, column 4, lines 40-44) coupled to the endoscope for the purpose of firmly holding the steering member to distal tip of the catheter shaft under a strong tension or stress (column 9, lines 46-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the steering mechanism of Kushner to incorporate a loop region surrounding a peripheral surface of the catheter shaft, a second body region extending along the catheter shaft, and a second end region coupled to the proximal end as taught by Miyagi for the purpose of firmly holding the steering member to distal tip of the catheter shaft under a strong tension or stress (column 9, lines 46-50).
Kushner in view of Miyagi is silent regarding a second end region coupled to the handle but one of ordinary skill in the art, when modifying Kushner in view of Miyagi will couple a second end region to the handle because Kushner already teaches connecting an end region of the steering member to the handle.
Furthermore, Mirzalou teaches a design of a steerable catheter (figure 1) comprising a second end region (end of one of elements 240a, 240b, 230a, 230b as a second body region) coupled to the handle (paragraph 0021, lines 3-6) for the purpose of controlling the deflection of the catheter in the desired direction by operating appropriate steering member (paragraph 0022).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the connection of a second end region of Kushner/Miyagi to incorporate a second end region coupled to the handle as taught by Mirzalou for the purpose of controlling the deflection of the catheter in the desired direction by operating appropriate steering member (paragraph 0022).
Regarding claim 17, Kushner discloses wherein the first end region (end of element 38 connected to element 39) is coupled to a steering actuator 22.
Kushner is silent regarding the second end region and therefore is silent regarding the second end region coupled to a steering actuator.
However, Mirzalou teaches wherein the second end region (end of selected elements 240a, 240b, 230a, 230b as a second body region) coupled to a steering actuator 125 for the purpose of controlling the steering of the catheter shaft in the desired direction (paragraph 0018).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the system of Kushner to incorporate the second end region coupled to a steering actuator as taught by Mirzalou for the purpose of controlling the steering of the catheter shaft in the desired direction (paragraph 0018).
Claim(s) 8, 9, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kushner (US 2009/0270835 A1) in view of Miyagi et al. (US 5,438,975) in view of Mirzalou et al. (US 2019/0175875 A1) and further in view of Lundquist et al. (US 5,254,088).
Regarding claim 8, Kushner/Miyagi/Mirzalou (hereinafter referred as “modified Kushner” discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 7. Modified Kushner is silent regarding the first end region and the second end of the elongate steering member extend in one or more loop formations at the steering connector.
However, Lundquist teaches a design of a steering handle wherein the first end region (end of element 370 in figure 10) and the second end region (end of element 360) of the elongate steering member 360, 370 extend in one or more loop formations at the steering connector 450 for the purpose of using a well-known alternative technique to control the steering of the catheter tip (column 8, lines 24-35).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the connection of the first end region and the second region of the elongate steering member of modified Kushner to incorporate extend in one or more loop formations at the steering connector as taught by Lundquist for the purpose of using a well-known alternative technique to control the steering of the catheter tip (column 8, lines 24-35).
Regarding claim 9, modified Kushner discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 7. Modified Kushner is silent regarding the first end region and the second end of the elongate steering member extend in an arrangement that resembles a figure eight at the steering connector.
However, Lundquist teaches a design of a steering handle wherein the first end region (end of element 370) and the second end region (end of element 360) of the elongate steering member 360, 370 extend in an arrangement that resembles a figure eight (figure 10) at the steering connector 450 for the purpose of using a well-known alternative technique to control the steering of the catheter tip (column 8, lines 24-35).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the connection of the first end region and the second region of the elongate steering member of modified Kushner to incorporate extend in an arrangement that resembles a figure eight at the steering connector as taught by Lundquist for the purpose of using a well-known alternative technique to control the steering of the catheter tip (column 8, lines 24-35).
Regarding claim 18, modified Kushner discloses the claimed invention substantially as claimed, as set forth above in claims 16 and 17. Modified Kushner is silent regarding the first end region and the second end of the elongate steering member extend in one or more loop formations adjacent to the steering actuator.
However, Lundquist teaches a design of a steering handle wherein the first end region (end of element 370 in figure 10) and the second end region (end of element 360) of the elongate steering member 360, 370 extend in one or more loop formations adjacent to the steering actuator 540 for the purpose of using a well-known alternative technique to control the steering of the catheter tip (column 8, lines 24-35).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the connection of the first end region and the second region of the elongate steering member of modified Kushner to incorporate extend in one or more loop formations adjacent to the steering actuator as taught by Lundquist for the purpose of using a well-known alternative technique to control the steering of the catheter tip (column 8, lines 24-35).
Regarding claim 19, modified Kushner discloses the claimed invention substantially as claimed, as set forth above in claims 16 and 17. Modified Kushner is silent regarding the first end region and the second end of the elongate steering member extend in an arrangement that resembles a figure eight adjacent to the steering actuator.
However, Lundquist teaches a design of a steering handle wherein the first end region (end of element 370) and the second end region (end of element 360) of the elongate steering member 360, 370 extend in an arrangement that resembles a figure eight (figure 10) adjacent to the steering actuator 540 for the purpose of using a well-known alternative technique to control the steering of the catheter tip (column 8, lines 24-35).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the connection of the first end region and the second region of the elongate steering member of modified Kushner to incorporate extend in an arrangement that resembles a figure eight adjacent to the steering actuator as taught by Lundquist for the purpose of using a well-known alternative technique to control the steering of the catheter tip (column 8, lines 24-35).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kushner (US 2009/0270835 A1) in view of Miyagi et al. (US 5,438,975) in view of Mirzalou et al. (US 2019/0175875 A1) and further in view of Pigott (US 2018/0318564 A1).
Regarding claim 10, modified Kushner discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Kushner is silent regarding wherein the length actuator includes a depressible button.
However, Pigott teaches a design of a catheter (figure 1) comprising the length actuator 31 includes a depressible button 31 for the purpose of allowing the length actuator to hold the desired length in the locking manner and unlock only when user desires to change the length (paragraph 0067).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the length actuator of modified Kushner to incorporate the length actuator includes a depressible button as taught by Pigott for the purpose of allowing the length actuator to hold the desired length in the locking manner and unlock only when user desires to change the length (paragraph 0067).
Claims 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kushner (US 2009/0270835 A1) in view of Miyagi et al. (US 5,438,975) in view of Mirzalou et al. (US 2019/0175875 A1) and further in view of Choudhury et al. (US 5,382,241).
Regarding claim 12, modified Kushner discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 11. Kushner further discloses a needle 18, the needle 18 being configured to pass through tissue into a position along the biliary and/or pancreatic tract. However, modified Kushner is silent regarding further comprising a needle releasably coupled to the needle attachment member.
However, Choudhury teaches a design of a syringe (figure 6) comprising a needle 56 releasably coupled to the needle attachment member 48 for the purpose of removing the needle when desired from the needle attachment member (column 3, lines 33-35, column 2, lines 54-56).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify a connection between the needle and the needle attachment member of modified Kushner to incorporate further comprising a needle releasably coupled to the needle attachment member as taught by Choudhury for the purpose of removing the needle when desired from the needle attachment member (column 3, lines 33-35, column 2, lines 54-56).
Regarding claim 20, Kushner discloses an endoscopic medical device assembly (figure 1), comprising:
a handle assembly 12 and a length adjustment member 21,
a length actuator 32 (one can hold element 32 to move element 21) coupled to the handle assembly 12, the length actuator 32 being configured to allow a user to vary the position of the handle relative to the length adjustment member 21 (paragraph 0044, lines 8-11);
a catheter shaft 26 coupled to the handle 12;
a steering actuator 22 coupled to the handle 12, the steering actuator being configured to steer the catheter shaft 26;
an elongate steering member 38 coupled to the steering actuator 22, the steering member 38 having a first end region (region of element 38 coupled to element 39) coupled to the handle 12, a first body region (region of element 38 extending from element 39 to 40) extending along the catheter shaft 26, a needle attachment member (member/portion of element 20 connected or enabling connection with element 18) releasably coupled to the handle region (region of element 12 comprising element 16), the needle 18 being configured to pass through tissue into a position along the biliary and/or pancreatic tract but is silent regarding a loop region extending about the catheter shaft, a second body region extending along the catheter shaft, and a second end region coupled to the handle.
However, Miyagi teaches a design of a steerable mechanism (figure 3) comprising a loop region 1a (figure 1) extending about the catheter shaft (when connected to element 3, element 2 would be surrounding a peripheral surface of element 3 which is a distal part of entire catheter shaft/tubular shaft comprising element 4 not completely shown in figures), a second body region (another portion of wire 1 extending from element 2) extending along the catheter shaft (another portion of wire 1 extending from element 2 is extending into element 4), and a second end region (end of another portion of wire 1 extending from element 2 coupled to proximal end of the endoscope, column 4, lines 40-44) coupled to the endoscope for the purpose of firmly holding the steering member to distal tip of the catheter shaft under a strong tension or stress (column 9, lines 46-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the steering mechanism of Kushner to incorporate a loop region surrounding a peripheral surface of the catheter shaft, a second body region extending along the catheter shaft, and a second end region coupled to the proximal end as taught by Miyagi for the purpose of firmly holding the steering member to distal tip of the catheter shaft under a strong tension or stress (column 9, lines 46-50).
Kushner in view of Miyagi is silent regarding a second end region coupled to the handle but one of ordinary skill in the art, when modifying Kushner in view of Miyagi will couple a second end region to the handle because Kushner already teaches connecting an end region of the steering member to the handle.
Furthermore, Mirzalou teaches a design of a steerable catheter (figure 1) comprising a second end region (end of one of elements 240a, 240b, 230a, 230b as a second body region) coupled to the handle (paragraph 0021, lines 3-6) for the purpose of controlling the deflection of the catheter in the desired direction by operating appropriate steering member (paragraph 0022).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the connection of a second end region of Kushner/Miyagi to incorporate a second end region coupled to the handle as taught by Mirzalou for the purpose of controlling the deflection of the catheter in the desired direction by operating appropriate steering member (paragraph 0022).
Kushner is further silent regarding further comprising a needle releasably coupled to the needle attachment member.
However, Choudhury teaches a design of a syringe (figure 6) comprising a needle 56 releasably coupled to the needle attachment member 48 for the purpose of removing the needle when desired from the needle attachment member (column 3, lines 33-35, column 2, lines 54-56).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify a connection between the needle and the needle attachment member of modified Kushner to incorporate further comprising a needle releasably coupled to the needle attachment member as taught by Choudhury for the purpose of removing the needle when desired from the needle attachment member (column 3, lines 33-35, column 2, lines 54-56).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kushner (US 2009/0270835 A1) in view of Miyagi et al. (US 5,438,975) in view of Mirzalou et al. (US 2019/0175875 A1) and further in view of Sutton (US 5,704,926).
Regarding claim 15, modified Kushner discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Kushner is silent regarding wherein the catheter shaft includes a first coil having a first pitch and a second coil having a second pitch different from the first pitch.
However, Sutton teaches a design of a catheter (figure 1) wherein the catheter shaft 10 includes a first coil having a first pitch and a second coil having a second pitch different from the first pitch (column 3, lines 34-40) for the purpose of imparting different flexibility in different sections of the catheter shaft thereby managing the pushability of the catheter shaft based on medical application (column 3, lines 34-48).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the catheter shaft of modified Kushner to incorporate wherein the catheter shaft includes a first coil having a first pitch and a second coil having a second pitch different from the first pitch as taught by Sutton for the purpose of imparting different flexibility in different sections of the catheter shaft thereby managing the pushability of the catheter shaft based on medical application (column 3, lines 34-48).
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Kushner (US 2009/0270835 A1) in view of Miyagi et al. (US 5,438,975) in view of Mirzalou et al. (US 2019/0175875 A1) and further in view of Andreas et al. (US 2005/0149159 A1).
Regarding claim 21, modified Kushner discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Kushner is silent regarding wherein the length adjustment member is directly coupled to the handle.
However, Andreas teaches a design a handle for controlling the length of the device (figure 1) wherein the length adjustment member 56 is directly coupled to the handle 28 for the purpose of using an alternative well-known configuration to control the extension and retraction of the catheter shaft (paragraph 0062).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the length adjustment member of modified Kushner to incorporate wherein the length adjustment member is directly coupled to the handle as taught by Andreas for the purpose of an alternative well-known configuration to control the extension and retraction of the catheter shaft (paragraph 0062).
Response to Arguments
Applicant's arguments filed 3/30/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claims 1, 16 and 20 have been considered but are moot because the arguments do not apply in view of the present rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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