DETAILED ACTION
Notice of 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/12/2026 has been entered.
Response to Arguments
Applicant's arguments filed 01/12/2026 have been fully considered but they are not persuasive | moot in view of the new grounds of rejection.
On page 9 of the Applicant’s response, it argues that Romo makes no mention of retracting a member from a catheter and sheath. However, it would have been obvious to one of ordinary skill in the art that nested elements of endoscopic/catheter devices may exhibit relative motion in a number of ways that befits the task. The minutiae between retraction of a catheter from a sheath, and a retraction of a generic elongate member from a catheter AND a sheath, would have been considered obvious to one with ordinary skill in the art because both teach that a tool may be retracted from a larger containing device.
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 may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim(s) 42, 45-48, 56, 60, and 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll (US 2007/0197896, of record) in view of Phee (US 2015/0230697, of record) in view of Hufford (US 2015/0157497).
Regarding claims 42, 56, and 61, Moll discloses a medical robotic system, method, and computer-readable storage medium storing instructions causing one or more processors to perform a method using a system ([0334]: “robotic catheter system”) comprising: a flexible elongate body including a lumen configured to receive a medical instrument (Figs. 192A-192Q show a flexible elongate body with a medical instrument received); a manipulator assembly comprising one or more actuators configured to manipulate the flexible elongate body ([0236]…[0238]: “actuated inputs”); and a control system configured to: determine an operational state of the medical robotic system; detect a motion actuation fault in one or more components of the medical robotic system ([0404]: “a mismatch between a) commanded instrument position based upon instrument and instrument driver kinematics and b) actual instrument position based upon fluoroscopy, ultrasound, localization…may be interpreted as an indication of contract or instrument fault (i.e. a broken steering tension member”). Moll does not explicitly disclose based on the operational state, in response to detecting the motion actuation fault: initiate retraction of the medical instrument relative to the lumen of the flexible elongate body, and after initiating retraction of the medical instrument relative to the lumen of the flexible elongate body, relaxing the flexible elongate body using the one or more actuators. However, Phee teaches withdrawing a flexible endoscopic device from a person after relaxing tensioning cables ([0120]: when the primary endoscope probe 100 is to be withdrawn from the environment in which it is disposed, the cables 120 can be de-tensioned or relaxed”). One with ordinary skill in the art would have found it obvious that if a fault as taught by Moll is detected, then a withdrawal or removal of the faulted instrument is very likely a next course of action. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the retraction and relaxation as taught by Phee, as to allow a faulted and inserted flexible instrument to be safely removed from a subject. Neither Moll nor Phee explicitly disclose that the retraction is initiating automatically in response to detecting a motion fault. However, Hufford teaches automatically stopping and/or retracting a catheter when a force sensor fault is detected ([0035]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the automated response of Hufford to the relaxation and withdrawal of Moll and Phee, as to provide robust automated control in preventing perforation to internal tissue (see Hufford @ [0035]).
Regarding claim 45, Moll discloses that the operational state comprises a position of the flexible elongate body within anatomical passageways ([0404]: “instrument position” is defined).
Regarding claims 46 and 60, Moll discloses that the operational state comprises one or more of a type of medical instrument ([0404]: the type of medical instrument is well-defined and exists as a “state” of the system).
Regarding claim 47, Moll discloses a medical instrument detector configured to detect a position of the medical instrument relative to the lumen ([0404]: “instrument position” is defined).
Regarding claim 48, Moll discloses that the operational state comprises a step within a workflow performed by the medical robotic system ([0404]: the step is that of detecting the fault).
Claim(s) 43, 44, 52, 53, and 57-59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll (US 2007/0197896, of record) in view of Phee (US 2015/0230697, of record) in view of Hufford (US 2015/0157497), as applied to claim 42, above, in view of Romo (US 2013/0317519, of record).
Regarding claims 43 and 57, neither Moll, Phee, nor Hufford, explicitly disclose that the control system is configured to maintain a shape of the flexible elongate body using the one or more actuators during at least a portion of the retraction of the medical instrument. However, Romo teaches controlling the relaxation of a flexible device during the navigation and control of the device ([0130]…[0138]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the control of Romo to the device of Moll, as to provide control over a device’s shape.
Regarding claims 44 and 58, neither Moll, Phee, nor Hufford, explicitly disclose that the control system is configured to relax the flexible elongate body after retraction of the medical instrument is complete. However, Romo teaches controlling the relaxation of a flexible device during the navigation and control of the device ([0130]…[0138]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the control of Romo to the device of Moll, as to provide control over a device’s shape.
Regarding claims 52 and 59, neither Moll, Phee, nor Hufford, explicitly disclose that the control system is configured to relax the flexible elongate body during retraction of the medical instrument. However, Romo teaches an “Autoretract” function for a catheter that involves relaxing the catheter ([0133]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the automatic retraction of Romo to the instrumentation of Moll, as to provide automated retraction.
Regarding claim 53, neither Moll, Phee, nor Hufford, explicitly disclose that the control system is configured to relax the flexible elongate body over a period of time and retraction of the medical instrument is performed within the period of time. However, Romo teaches an “Autoretract” function for a catheter that involves relaxing the catheter over a period of time ([0133]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the automatic retraction of Romo to the instrumentation of Moll, as to provide automated retraction.
Claim(s) 49 and 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll (US 2007/0197896, of record) in view of Phee (US 2015/0230697, of record) in view of Hufford (US 2015/0157497), as applied to claim 42 above, in view of Roelle (US 2011/0319815, of record).
Regarding claim 49, neither Moll, Phee, nor Hufford, explicitly disclose an optical fiber shape sensor, wherein the one or more components of the medical robotic system includes the shape sensor. However, Roelle teaches an optical fiber shape sensor ([0138]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the shape sensor of Roelle to the instrument of Moll, as to provide shape detection of a luminal instrument.
Regarding claim 55, neither Moll, Phee, nor Hufford, explicitly disclose that the one or more actuators comprises an insertion actuator configured to move the flexible elongate body along an insertion axis, and wherein the control system is further configured to, in response to detecting the motion actuation fault, control the insertion actuator to prevent movement of the flexible elongate body along the insertion axis. However, Roelle teaches that movement of a shapeable instrument may be stopped and reversed ([0033]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the prevention of movement as taught by Roelle to the instrument of Moll, as to provide control over the movement of the instrument.
Claim(s) 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll (US 2007/0197896, of record) in view of Phee (US 2015/0230697, of record) in view of Hufford (US 2015/0157497), as applied to claim 42 above, in view of Stahler (US 2012/0071895, of record).
Regarding claim 54, neither Moll, Phee, nor Hufford, explicitly disclose that detecting the motion actuation fault comprises comparing signals from two or more redundant sensors. However, Stahler teaches using redundant sensing for error detection ([0684]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the redundant sensing of Stahler to the device of Moll, as to provide robust sensing.
Conclusion
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/JASON M IP/
Primary Examiner, Art Unit 3793