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 .
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.
Claim(s) 6-7, 9-10, 13-14, 20, 26-28, and 30-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hauck (US 20070185404 A1– previously cited) in view of Popovic (US 20160338787 A – previously cited) in view of Hwang (US 20210369366 A1).
In regards to claim 6 Hauck teaches an apparatus comprising a robotic system, the robotic system comprising:
a receiving module extending along a longitudinal axis and configured to releasably receive at least a handle of a steerable sheath after a distal end of the steerable sheath has been manually introduced into a patient independently of the robotic system ([0040-0041] Fig.1 a track 14, a catheter holding device 16, and catheter receiving portion 26 are a receiving module that receive catheter control handle 28 which is configured to be interested into a patient);
a steering drive module configured to robotically operate at least one interface of the handle to selectively control an actuator module of the handle to actuate at least one guidewire of the steerable sheath such that the distal end of the steerable sheath is controllably deflected ([0051] “In particular, catheter deflection actuator 58 may be operatively coupled to catheter deflection control mechanism 20 such that catheter deflection control mechanism 20 can actuate catheter deflection actuator 58 to selectively tension one or more pull wires 50 and deflect the distal end 52 of catheter 12 by a desired amount in a desired direction.”, deflection servo mechanism 22 is a steering drive module);
and, an axial drive module configured to robotically translate the steerable sheath ([0046] “Translation servo mechanism 18 is operatively coupled to catheter holding device 16 and adapted to control translation of catheter holding device 16 relative to track 14 in order to adjust the lateral position of catheter holding device 16 along track 14”), wherein:
the at least one interface is an interface configured for manual manipulation by a human operator (Fig.9 Human operator can interact with deflection control mechanism 20), and the robotic system is configured such that, without the distal end of the steerable sheath being withdrawn from the patient, the handle is removable from the robotic system into a manual mode (0066] “As described above, catheter 12 can be quickly and easily disconnected from catheter holding device 16. Thus, if the user desires to manually control catheter 12 at any point during the procedure, the user may disconnect catheter 12 from the catheter holding device 16 as described above”).
Hauck fails to teach an electrically powered actuator module of the handle. Popovic teaches a steerable guidewire controlled with an electrically powered actuator ([0015]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to substitute the manual actuator of Hauck with an electrically powered actuator like the one described in Popovic. Doing so would merely be a simple substitution of one known element for another (an electrically powered rotational actuator for a mechanically powered rotational actuator) to obtain predictable results.
Modified Hauck fails to teach a device wherein the handle and the steerable sheath are removable from the robotic system into a manual mode in which the handle and the steerable sheath are physically unattached to the robotic system to an entry point into the patient. Hwang teaches completely detaching a controllable catheter from a robotic system (Fig. 8A, [0083] “While the user is inserting the probe, the user is monitoring the camera view on the monitor (display section 505), while steering the probe tip using the catheter tip control”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the catheter of modified Hauck to completely detach from the robotic system entirely like the device of Hwang. Doing so would be combining prior art elements according to known methods to yield the predictable result of allowing an operator to manually move the entire catheter allowing for more control when inserting.
In regards to claim 7 modified Hauck teaches the apparatus of claim 6, wherein the handle and the steerable sheath are removable from the robotic system into the manual mode without disconnecting a conduit of the steerable sheath from the handle (Hauck Fig.9 Catheter is only disconnected from the robotic system, Handle is still connected to steerable sheathe).
In regards to claim 9 modified Hauck teaches the apparatus of claim 6,wherein the at least one interface comprises a collar rotatable about the handle (Hauck [0050] catheter deflection actuators 55 are shown in Fig. 9 as as collar rotatable about the handle).
In regards to claim 10 modified Hauck teaches the apparatus of claim 6, wherein the at least one interface comprises a linear slide (Hauck [0050] “catheter deflection actuators 58 may take many other forms, including, but not limited to, sliders and switches, without departing from the spirit and scope of the present invention’).
In regards to claim 13 modified Hauck teaches the apparatus of claim 6, wherein the distal end of the steerable sheath is configured to be manually introduced into the patient independently of an introducer of the robotic system (See arguments for claim 6, Hwang [0083] teaches manual introduction, Hauck [0061] teaches introducer is optional).
In regards to claim 14 modified Hauck teaches the apparatus of claim 6, wherein the axial drive module is configured to robotically retract the steerable sheath ([0051] “Returning to FIG. 1, when catheter control handle 28 is received within catheter receiving portion 26, catheter 12 translates relative to track 14 with catheter holding device 16, thereby providing a first degree of freedom permitting catheter 12 to be advanced into and retracted from a patient's body”).
In regards to claim 20, modified Hauck teaches the apparatus of claim 6, wherein the axial drive module is configured such that translating the steerable sheath comprises translating the receiving module in a directions parallel to the longitudinal axis (Hauck “[0051] Returning to FIG. 1, when catheter control handle 28 is received within catheter receiving portion 26, catheter 12 translates relative to track 14 with catheter holding device 16, thereby providing a first degree of freedom permitting catheter 12 to be advanced into and retracted from a patient's body).
In regards to claim 26 modified Hauck teaches the apparatus of claim 6, wherein the receiving module comprises the steering drive module and the axial drive module in a single unit (Fig 9 catheter deflection actuator 58 and Translation servo mechanism 18 are both part of the robotic unit that controls the catheter when it isn’t in manual mode).
In regards to claim 27 modified Hauck teaches the apparatus of claim 26. Modified Hauck does not explicitly teach a device wherein the single unit is manually repositionable between surfaces. However, It would be obvious to move robotic mechanism and catheter to any surface including one anchored to the patient in order to position the device for use.
In regards to claim 28 modified Hauck teaches the apparatus of claim 27, wherein the single unit is configured to be mounted to the patient such that the steerable sheath is selectively anchored to the patient via the single unit (see arguments for claim 27).
In regards to claim 30 modified Hauck teaches the apparatus of claim 6, wherein the receiving module comprises a plurality of coupling members configured to releasably couple to the handle ([0041] “Accordingly, catheter control handle 28 may be secured in catheter receiving portion 26 by a frictional fit or with one or more quick-release fasteners”). Modified Hauck fails to teach the coupling members coupling to opposing ends of the handle. However, it would have been prima facie obvious to a person of ordinary skill in the art to add another coupling member on the other side of the handle in order to make the connection stable especially if the introducer is not present. Doing so would be a mere duplication of parts.
In regards to claim 31 modified Hauck teaches the apparatus of claim 30, wherein the steering drive module comprises a drive member configured to robotically operate the at least one interface at least by releasably engaging an element of the at least one interface via complementary patterns (Hauck [0052] In some embodiments of the invention, rotating catheter deflection control mechanism 20 will rotate catheter deflection actuator 58 in turn, thereby selectively tensioning one or more pull wires 50 within catheter 12)..
In regards to claim 32 modified Hauck teaches the apparatus of claim 30, wherein at least one of the plurality of coupling members are manually operated such that the handle is rapidly translatable by the human operator away from the longitudinal axis out of the steering drive module into the manual mode.
In regards to claim 33 modified Hauck teaches the apparatus of claim 32, wherein a drive member of the steering drive module that engages the at least one interface is disposed such that the handle is removable from the receiving module without manipulating the drive member (Hauck Fig. 9 Drive member isn’t manipulated when the catheter is removed).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hauck (US 20070185404 A1) in view of Popovic (US 20160338787 A) in view of Hwang (US 20210369366 A1) as applied to claim 6 further in view of Shelton (US 20190200977 A1 – previously cited).
In regards to claim 11, modified Hauck teaches the apparatus of claim 8, wherein the at least one interface can take many forms (Hauck [0050]). Modified Hauck fails to teach a device wherein the at least one interface comprises a lever. Shelton teaches a lever for controlling a motor ([1346]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to make the interface of modified Hauck a lever like the interface of Shelton. Doing so would merely be choosing from a finite number of identified, predictable solutions (collar, buttons, lever, joystick, touchpad, linear slide) with a reasonable expectation of success in order to control the device.
In regards to claim 12, modified Hauck teaches the apparatus of claim 8, wherein the at least one interface can take many forms (Hauck [0050]). Modified Hauck fails to teach a device wherein the at least one interface comprises an electronic touch input. Shelton teaches a touch input for controlling a motor ([1346]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to make the interface of modified Hauck a touch interface like the one of Shelton. Doing so would merely be choosing from a finite number of identified, predictable solutions (collar, buttons, lever, joystick, touchpad, linear slide) with a reasonable expectation of success in order to control the device.
Claim(s) 15, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hauck (US 20070185404 A1– previously cited) in view of Popovic (US 20160338787 A– previously cited) in view of Hwang (US 20210369366 A1) as applied to claim 6 further in view of Marchand (US 20080065011 A1– previously cited).
In regards to claim 15, modified Hauck teaches the apparatus of claim 6, further comprising a control module configured to control motion of the steerable sheath relative to the patient body (Hauck “[0051] Returning to FIG. 1, when catheter control handle 28 is received within catheter receiving portion 26, catheter 12 translates relative to track 14 with catheter holding device 16, thereby providing a first degree of freedom permitting catheter 12 to be advanced into and retracted from a patient's body”). Modified Hauck fails to teach a dilator coupled to the patient. Marchand teaches using a dilator that expands the inner diameter of the body vessel in order to introduce a guidewire and device ([0090]). It would be prima facie obvious to a person of ordinary skill in the art to modify the device of modified Hauck to include a dilator that expands an inner diameter of the body vessel for the steerable sheath to enter like the device of Marchand. Doing so would be combining prior art elements according to known methods to yield the predictable result of allowing the steerable sheath to more easily enter a lumen in the patient.
In regards to claim 17, modified Hauck teaches the apparatus of claim 15, wherein the motion comprises at least one of insertion and extraction (Hauck “[0051] Returning to FIG. 1, when catheter control handle 28 is received within catheter receiving portion 26, catheter 12 translates relative to track 14 with catheter holding device 16, thereby providing a first degree of freedom permitting catheter 12 to be advanced into and retracted from a patient's body”).
In regards to claim 18, modified Hauck teaches the apparatus of claim 15, wherein the motion comprises rotation about an axis of rotation parallel to the longitudinal axis. ([0099] Preferably, a processor, which may be part of computer system 92, causes probe 12 to automatically move into meaningful proximity with a plurality of surface points, for example by providing instructions to controller 24 incorporated in robotic surgical system 10 to actuate one or more of servo mechanisms 18, 22, 60 to translate, deflect, and/or rotate probe 12).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hauck (US 20070185404 A1 – previously cited) in view of Popovic (US 20160338787 A – previously cited) in view of Hwang (US 20210369366 A1) in view of Marchand (US 20080065011 A1 – previously cited) as applied to claim 15, further in view of Vollmers (US 20130165964 A1 – previously cited).
In regards to claim 16, modified Hauck teaches the apparatus of claim 15, wherein the control module is further configured to control motion of the steerable sheath relative to a proximal end of the dilator (see arguments in regards to claim 15). Modified Hauck fails to teach an apparatus wherein the dilator is sutured to the patient. Vollmers teaches a way of anchoring an implantable device to a blood vessel using sutures ([0030][0035]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to anchor the dilator to the patient using a suture like the method of Vollmers. Doing so would allow for the dilator to stay in place when the steerable sheath is being inserted.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hauck (US 20070185404 A1 – previously cited) in view of Popovic (US 20160338787 A – previously cited) in view of Hwang (US 20210369366 A1) in view of Marchand (US 20080065011 A1– previously cited) as applied to claim 18, further in view of Piecuch (US 20170325906 A1 – previously cited).
In regards to claim 19, modified Hauck teaches the apparatus of claim 18 including the receiving module comprising a cradle configured to releasably receive the handle (Hauck “[0041] Catheter holding device 16 includes a catheter receiving portion 26. Catheter receiving portion 26 is configured to receive catheter 12 by installing a catheter control handle 28, located near a proximal end 30 of catheter 12, into catheter receiving portion 26”, catheter receiving portion is cradle). Modified Hauck fails to teach a frame rotatably suspending the cradle such that the cradle rotates about an axis of rotation relative to the frame. Piecuch teaches a frame (first proximal portion 68) and that supports an instrument holder (instrument holder 70) and allows the entire instrument to rotate ([0038]). It would be prima facie obvious to a person of ordinary skill in the art to attach the catheter holding device of modified Hauck to a frame with a rotatable motor like the device of Piecuch that allows the entire instrument to move about a rotational axis. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of providing another axis of rotation for the device to be positioned relative to the patient.
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hauck (US 20070185404 A1– previously cited) in view of Popovic (US 20160338787 A– previously cited) in view of Hwang (US 20210369366 A1) as applied to claim 6, further in view of Blumenkranz (US 20140257333 A1 – previously cited).
In regards to claim 21, modified Hauck teaches the apparatus of claim 6. Modified Hauck fails to teach the receiving module further comprises a monitor configured to display a visual display of a status in the steerable sheath. Blumenkranz teaches a receiving module comprising a monitor configured to monitor detect a visual display of a deflection status in the steerable sheath. (Blumenkranz [0060] “An optical fiber 316 passes through the handpiece 312 and the flexible body 314 for measuring the shape of the flexible body or for recording images from the distal end of the flexible body.”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hauck to include the optical fiber sensor and modify the controller to determine the shape of the catheter like the device of Blumenkranz. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of allowing the user to know of the catheters shape while it is inside the patient.
In regards to claim 22, modified Hauck teaches the apparatus of claim 21, wherein the monitor comprises an optical sensor (Blumenkranz [0060] Optical Fiber).
Claims 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Hauck (US 20070185404 A1 – previously cited) in view of Popovic (US 20160338787 A – previously cited) in view of Hwang (US 20210369366 A1) as applied to claim 6, further in view of Tegg (US 20200085483 A1 – previously cited).
In regards to claim 21, modified Hauck teaches the apparatus of claim 6. Modified Hauck fails to teach the receiving module further comprises a monitor configured to display a visual display of a status in the steerable sheath. Tegg teaches a receiving module comprising a monitor configured to monitor detect a visual display of a deflection status in the steerable sheath (Tegg [0029] magnetic positioning sensors for use in positioning a catheter into a lumen in a patient). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hauck to include the magnetic positioning sensors and modify the controller to determine the shape of the catheter like the device of Blumenkranz. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of allowing the user to know of the catheters position while it is inside the patient.
In regards to claim 23, modified Hauck teaches the apparatus of claim 21, wherein the monitor comprises a magnetic sensor (Tegg [0029] magnetic positioning sensors for use in positioning a catheter into a lumen in a patient).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Hauck (US 20070185404 A1 – previously cited) in view of Popovic (US 20160338787 A – previously cited) in view of Hwang (US 20210369366 A1) as applied to claim 6, further in view of Sholev (US 20190069917 A1 – previously cited).
In regards to claim 24, Modified Hauck teaches the apparatus of claim 6. Modified Hauck fails to teach an apparatus wherein the steerable sheath further comprises a battery operably coupled to supply power to the actuator of the handle. Sholev teaches a medical instrument with a battery pack in the handle to supply power to the instrument ([0096]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to power the catheter of modified Hauck with a battery located in the handle like the device of Sholev. Doing so would allow for the steerable sheath to be wireless when in manual mode.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Hauck (US 20070185404 A1 – previously cited) in view of Popovic (US 20160338787 A – previously cited) in view of Hwang (US 20210369366 A1) as applied to claim 6, further in view of Cohen (US 20110105954 A1).
In regards to claim 29, Modified Hauck teaches the apparatus of claim 6. Modified Hauck fails to teach an apparatus wherein the robotic system further comprises an actuator configured to slew the receiving module relative to a base of the robotic system such that the steerable sheath is selectively angled relative to the longitudinal axis. Cohen teaches a catheter insertion system an actuator configured to slew a steerable sheath so that it is selectively angled relative to the longitudinal axis ([0304] Connector member 406 can tilt elongated plate 404 vertically up or down in a lever-like manner in order to better position the catheter. Optionally elongated plate 404 can be rotated in planar fashion on connector member 406 as well). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the apparatus of modified Hauck to tilt upward and downward like the device of Cohen. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of allowing the device to be tilted toward the patient in order to better position it.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Hauck (US 20070185404 A1 – previously cited) in view of Popovic (US 20160338787 A – previously cited) in view of Hwang (US 20210369366 A1) as applied to claim 33, in view of Fenech (US 20170265953 A1).
In regards to claim 34, modified Hauck teaches the apparatus of claim 33. Modified Hauck fails to teach an apparatus wherein the at least one of the plurality of coupling members is spring loaded. Fenech teaches a spring-loaded clamp connection for use in connecting an instrument body and an assembly ([0056] “The coupling 327 rigidly couples the retractable channel assembly 302 to the instrument body 360 at the coupling member 364, for example via a spring-loaded clamp connection”). Doing so would merely be combining prior art elements according to known methods to yield the predictable result of allowing the device to be tilted toward the patient in order to better position it.
Response to Arguments
Applicant’s arguments, see remarks, filed 04/29/2026, with respect to the 35 U.S.C. 101 rejections of claims 13, 16, and 25 have been fully considered and are persuasive. The 35 U.S.C. 101 rejections of claims 13, 16, and 25 have been withdrawn.
Applicant’s arguments, see remarks, filed 04/29/2026, with respect to the 35 U.S.C. 112(b) rejections of claims 13, 19, 20, and 25 have been fully considered and are persuasive. The35 U.S.C. 112(b) rejections of claims 13, 19, 20, and 25 h has been withdrawn.
Applicant’s arguments, see remarks filed 04/29/2026, with respect to the 35 U.S.C. 103 rejection(s) of claim(s) 6 and it’s dependent claims under Claims 6, 13-14, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Blumenkranz (US 20140257333 A1) in view of Popovic (US 20160338787 A) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hauck (US 20070185404 A1) in view of Popovic (US 20160338787 A) in view of Hwang (US 20210369366 A1).
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 LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
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/LUCY EPPERT/ Examiner, Art Unit 3791
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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