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
Acknowledgment is made to the amendment received 10/2/2025.
Response to Arguments
Applicant's arguments filed 10/2/2025 have been fully considered but they are not persuasive. Regarding claim 1, applicant argues that without hindsight, a person of ordinary skill in the art would not modify the medical instrument described in Remiszewski. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Remiszewski discloses the claim language “wherein the handle includes an actuating portion connected to the wire filament and the one or more steering wires; and wherein the actuating portion includes a manipulating element coupled to the one or more steering wires and configured to radially adjust about a rotational joint”, while Wu discloses a medical instrument wherein the rotational joint is a rotational ball-socket joint, as seen in paragraph [0281] of Wu. Thus, as seen below, based on the Wu reference, having the rotational joint specifically be a rotational ball-socket joint is considered within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure. Thus, claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Remiszewski in view of Wu.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-5, 7-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Remiszewski et al., US 20070282358, herein referred to as “Remiszewski”, in view of Wu et al., US 20110264011, herein referred to as “Wu”.
Regarding claim 1, Remiszewski discloses a medical device (Figures 3A-B) comprising: an elongate tube (Figures 3A-B: shaft 140) having a proximal end (Figure 3A: end near control handle 144) and a distal end (Figures 3A-B: end effector 100) configured to be directed toward an opening of a body lumen ([0011]); a wire filament extending along the elongate tube (Figure 3B: cutting wire 109), a distal end of the wire filament connected to the distal end of the elongate tube ([0085]: “at which point the bowing wire 109 enters another sidewall port (as illustrated in FIG. 4B) and is anchored inside the end effector 100.”), a proximal portion of the wire filament extending at least partially along the elongate tube ([0085]: “the cutting wire 109 extends from the user handle 144 distally through the shaft 140 to a point near or within the end effector 100”), and a distal portion of the wire filament extending external to the elongate tube ([0085]: “ at which point the cutting wire exits the inside of the shaft 140 through a sidewall port and runs distally along the outside of end effector to a point proximal to the tip 108 of the end effector 100”); a steerable distal tip extending distal of the distal end of the wire filament (Figure 3B: end effector 100); and a handle (Figure 3A: handle 144 and Figure 8B) in mechanical communication with the steerable distal tip ([0118]: “The stiffening wires aid the shaft 140 in transmitting motion from the control handle of the device to the tip 108 of the end effector 100 and can allow the user to maintain precise control.”); and one or more steering wires extending from the handle to the steerable distal tip (Figure 7: first and second steering wire lumens 192 and 193); wherein the handle is configured to be adjusted to control a position of the steerable distal tip in at least three directions ([0085]); wherein adjustment of the handle causes tension on one or more of the one or more steering wires to adjust the position of the steerable distal tip ([0085]: “In other embodiments, the instrument may have a left steering control wire and a right steering control wire in addition to the main bowing or cutting wire. Tension applied to the left steering control wire causes the distal end 108 of the end effector to bend left. Tension applied to the right steering control wire causes the distal end 108 of the end effector 100 to bend right. ”); wherein the handle (Figure 8B) includes an actuating portion connected to the wire filament and the one or more steering wires ([0122]); and wherein the actuating portion includes a manipulating element coupled to the one or more steering wires and configured to radially adjust about a rotational joint (Figure 8B: multi-directional control 236). Remiszewski does not explicitly disclose a medical device wherein the rotational joint is a rotational ball-socket joint.
However, Wu teaches a medical device (Figure 17) wherein the rotational joint is a rotational ball-socket joint ([0281]: “ the actuator 260 of handle assembly 200 comprises a ball-and socket joint for controlled multi-directional deflection of the second flexure zone 34 via controlled pulling on one or more control wires 40 that proximally terminate at the actuator and distally terminate in the second flexure zone.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical device disclosed by Remiszewski so that the rotational joint is a rotational ball-socket joint as taught by Wu for controller multi-directional deflection of the device (Wu [0281]).
Regarding claim 4, Remiszewski in view of Wu discloses the medical device of claim 1, and Remiszewski further discloses a medical device wherein actuation of the actuating portion in a radial direction adjusts the position of the steerable distal tip ([0122]).
Regarding claim 5, Remiszewski in view of Wu discloses the medical device of claim 1, and Remiszewski further discloses a medical device wherein: actuation of the actuating portion in an axial direction causes the distal end of the elongate tube to flex (Figure 8C: bowing/cutting control drive 240 moves in an axial direction along the longitudinal axis and [0122]: “Rotating the bowing/cutting wheel 240 in the proximal direction tensions the bowing/cutting wire 109 and causes the device to bow in the cutting plane. ”); and actuation of the actuating portion in a radial direction adjusts the radial position of the steerable distal tip ([0122]: “Rotating the multi-directional control 236 to the operator's right moves the tip 108 of the end effector 100 of the device to the right. Rotating the multi-directional control 236 to the operator's left moves the tip 108 of the end effector 100 to the left. ”).
Regarding claim 7, Remiszewski in view of Wu discloses the medical device of claim 1, and Remiszewski further discloses a medical device wherein: the one or more of the steering wires extend through at least a portion of the elongate tube (Figure 7: first and second steering wire lumens 192 and 193); and the elongate tube includes a first lumen for receiving the wire filament (Figure 7: cutting wire or third steering control wire lumen 196) and one or more lumens each configured to receive one of the one or more steering wires (Figure 7: first and second steering wire lumens 192 and 193).
Regarding claim 8, Remiszewski in view of Wu discloses the medical device of claim 1, and Remiszewski further discloses a medical device wherein the one or more steering wires include at least three steering wires extending from the handle to the steerable distal tip (Figure 7: first and second steering wire lumens 192 and 193 and stiffening wire lumens 200).
Regarding claim 9, Remiszewski in view of Wu discloses the medical device of claim 1, and Remiszewski further discloses a medical device wherein adjustment of the handle in a radial direction relative to the elongate tube is configured to adjust the position of the steerable distal tip ([0122]: “Rotating the bowing/cutting wheel 240 in the proximal direction tensions the bowing/cutting wire 109 and causes the device to bow in the cutting plane.”).
Regarding claim 10, Remiszewski in view of Wu discloses the medical device of claim 1, and Remiszewski further discloses a medical device wherein the handle is in communication with the proximal portion of the wire filament and adjustment of the handle in an axial direction of the elongate tube is configured to cause the distal end of the elongate tube to flex and expose a cutting portion of the wire filament ([0122]: “Rotating the bowing/cutting wheel 240 in the proximal direction tensions the bowing/cutting wire 109 and causes the device to bow in the cutting plane.”).
Regarding claim 11, Remiszewski in view of Wu discloses the medical device of claim 1, and Remiszewski discloses a system (Figures 3A-B), comprising: an endoscope (Figure 2A: endoscope 112) having a proximal end with an axial opening ([0067]: “ the instrument is a sphincterome with a cutting wire 109 in the bowed position, emerging from the distal end of an endoscope 112”), a distal end with a radial opening (Figures 1 and 2A) and a working channel extending therebetween ([0067]: “ the instrument is a sphincterome with a cutting wire 109 in the bowed position, emerging from the distal end of an endoscope 112”); a guidewire (Figure 7: guide wire lumen 185); and the medical device of claim 1 (Figures 3A-B) extendable through the working channel (Figure 1) and configured to be directed toward the opening of the body lumen ([0011]), wherein the distal end of the elongate tube (Figures 3A-B: end effector 100) is configured to extend through the radial opening (Figure 3B); wherein the steerable distal tip is configured to extend through the radial opening (Figures 3A-B: end effector 100); and wherein the handle is configured to be adjusted to adjust a radial position of the steerable distal tip ([0122]: “Rotating the bowing/cutting wheel 240 in the proximal direction tensions the bowing/cutting wire 109 and causes the device to bow in the cutting plane.”).
Regarding claim 12, Remiszewski in view of Wu discloses the system of claim 11, and Remiszewski further discloses a system wherein actuation of the actuating portion in a radial direction adjusts the position of the steerable distal tip ([0122]).
Regarding claim 13, Remiszewski in view of Wu discloses the system of claim 11, and Remiszewski further discloses a system wherein actuation of the actuating portion in an axial direction causes the distal end of the elongate tube to flex (Figure 8C: bowing/cutting control drive 240 moves in an axial direction along the longitudinal axis and [0122]: “Rotating the bowing/cutting wheel 240 in the proximal direction tensions the bowing/cutting wire 109 and causes the device to bow in the cutting plane. ”) and expose a cutting portion of the wire filament ([0122]: “Rotating the bowing/cutting wheel 240 in the proximal direction tensions the bowing/cutting wire 109 and causes the device to bow in the cutting plane.”)
Regarding claim 14, Remiszewski in view of Wu discloses the system of claim 11, and Remiszewski further discloses a system wherein one or more of the steering wires extend through at least a portion of the elongate tube (Figure 7: first and second steering wire lumens 192 and 193); and wherein the elongate tube includes a first lumen for receiving the wire filament (Figure 7: cutting wire or third steering control wire lumen 196) and one or more lumens each configured to receive one of the one or more steering wires (Figure 7: first and second steering wire lumens 192 and 193).
Regarding claim 15, Remiszewski in view of Wu discloses system of claim 11, and Remiszewski further discloses a system wherein the one or more steering wires include at least three steering wires extending from the handle to the steerable distal tip (Figure 7: first and second steering wire lumens 192 and 193 and stiffening wire lumens 200).
Regarding claim 16, Remiszewski in view of Wu discloses the system of claim 11, and Remiszewski discloses a method ([0012]) of accessing a body lumen of a subject with the system of claim 11 ([0011]), the method comprising: extending the endoscope (Figure 2A: endoscope 112) into the body lumen of the subject ([0012]: “comprising the steps of providing a flexible endoscope having an instrument channel and an exit port; providing a steerable medical instrument sized to fit through the Papilla of Vater; navigating the endoscope through the patient's body”); extending the elongate tube (Figures 3A-B: shaft 140 and [0012]: “ introducing the steerable medical instrument through the instrument channel of the endoscope and advancing the instrument until the distal end of the instrument protrudes from the exit port; ”) through the working channel (Figure 7); directing the distal end of the elongate tube through an opening of the body lumen ([0012]: “advancing the instrument until the distal end of the instrument protrudes from the exit port;”); and steering the steerable distal tip toward a duct located distal of the opening of the body lumen ([0012]: “further advancing and steering the instrument to enter and cannulate the Papilla, wherein the steering is achieved by tensioning at least one steering control wire.” And [0004]).
Regarding claim 17, Remiszewski in view of Wu discloses the method of claim 16, and Remiszewski further discloses a method wherein steering the steerable distal tip comprises radially adjusting the handle (Figure 8B) to steer the steerable distal tip toward the duct ([0122]).
Regarding claim 18, Remiszewski in view of Wu discloses the method of claim 16, and Remiszewski further discloses a method wherein steering the steerable distal tip comprises radially adjusting the manipulating element (Figure 8B: multi-directional control 236) about the rotational joint to steer the steerable distal tip toward the duct ([0122]). Wu teaches a method (Figure 17) wherein the rotational joint is a rotational ball-socket joint ([0281]: “ the actuator 260 of handle assembly 200 comprises a ball-and socket joint for controlled multi-directional deflection of the second flexure zone 34 via controlled pulling on one or more control wires 40 that proximally terminate at the actuator and distally terminate in the second flexure zone.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Remiszewski so that the rotational joint is a rotational ball-socket joint as taught by Wu for controller multi-directional deflection of the device (Wu [0281]).
Regarding claim 19, Remiszewski in view of Wu discloses the method of claim 16, and Remiszewski further discloses a method further comprising: extending the guidewire through the steerable distal tip and into the duct (Figure 7: guidewire lumen 185).
Regarding claim 21, Remiszewski in view of Wu discloses the method of claim 16, and Remiszewski further discloses a method wherein the steerable distal tip is steered through the radial opening ([0071]: “FIG. 2A demonstrates the end effector 100 emerging from the distal end of an endoscope 112 navigating through a patient's anatomy 122. ”).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Remiszewski in view of Wu, further in view of Wilder et al., US 20200214764, herein referred to as “Wilder”.
Regarding claim 20, Remiszewski in view of Wu discloses the method of claim 19, but does not explicitly disclose a method further comprising: removing the elongate tube from the body lumen and the working channel of the endoscope while maintaining the guidewire in the duct; and inserting another elongate tube over the guidewire and into the duct.
However, Wilder teaches a method further comprising: removing the elongate tube from the body lumen and the working channel of the endoscope while maintaining the guidewire in the duct; and inserting another elongate tube over the guidewire and into the duct ([0043]: “ A guidewire may be extended through the elongate tube into the body lumen. The elongate tube may be removed from about the guidewire and the working channel such that the guidewire may be left within the working channel and the body lumen. Another instrument may be inserted within the working channel over the guidewire and into the body lumen.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Remiszewski so that it includes removing the elongate tube from the body lumen and the working channel of the endoscope while maintaining the guidewire in the duct; and inserting another elongate tube over the guidewire and into the duct as taught by Wilder to limit the time taken if a procedure required multiple instruments, which reduces post-procedure complications (Wilder [0024]).
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 Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NORA W RHODES/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794