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 on 9/4/2026 has been entered. Claims 1-20 remain pending the application.
Response to Arguments
Applicant's arguments filed on 9/4/2026 have been fully considered but they are not persuasive or are moot.
Applicant argues on page 7 that the 112b issues have been resolved by amendment. However, one simple 112b issue inadvertently remains as outlined in the rejection below. Accordingly, this argument is not persuasive.
Applicant argues on pages 8-11 that the previously cited art does not disclose the newly added limitations to the claims related to detecting the centerline and endpoints within images. This argument is moot in view of the new grounds of rejection necessitated by amendment which relies on Bell et al. (US20230000563, hereafter Bell) to disclose these limitations in the claims. Accordingly, this argument is moot.
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 1-20 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.
Regarding claim 1, the claim recites “a catheter drive system” in line 4, but the claims have been amended to recite an interventional device to address a previous 112b rejection. Therefore, it is unclear how this drive system relates to the interventional device. For examination purposes, this limitation will be interpreted as reciting “an interventional device drive system”.
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, 3, 5-11, 13, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kariv et al. (US20170311908, hereafter Kariv) and Bell et al. (US20230000563, hereafter Bell).
Regarding claims 1 and 13, Kariv discloses a system for detecting interventional device prolapse and a method of robotically controlling an interventional device (Kariv, Para 2; “The instant invention relates generally to detection methods for use in medical systems. In particular, the instant invention relates to prolapse and tool/device dislodgement detection systems and methods”), the system and method comprising:
one or more processors (Kariv, Figure 1) (Kariv, Para 23-24; “With continued reference to FIG. 1, the system 10 as depicted includes a main control 12 (e.g., a processor) having various input/output mechanisms 14, […] The control 12, in a computer-implemented embodiment, is programmed to perform a plurality of functions, including a medical tool dislodgement detection function 28 (hereafter sometime detection block 28) and a guidewire prolapse detection function 30 (hereinafter sometimes detection block 30)”) configured to receive a plurality of images from an imaging system (Kariv, Para 25; “Embodiments consistent with the invention may find use in applications that display imaging of a region of interest and therefore the system 10 may include the image database 18. The image database 18 may be configured to store image information relating to the patient's body, for example a region of interest surrounding a reference location where a medical tool has been parked or alternatively a region of interest surrounding a location where a guidewire prolapse condition has been detected”) and drive system sensor data from an interventional device drive system (Kariv, Para 64; “The proximal motion detecting device 72 may be configured to detect the length of guidewire 26 b passing past the proximal motion device 72 and generate a length-indicative signal that is provided to the detection block 30”) (Kariv, Para 34; “a second MPS location sensor 24 2 is coupled at another location more proximal of sensor 24 1 and may be at the proximal end of the tool 26 a”), the one or more processors further configured to:
determine a first position of interventional device, the first position comprising at least a first observed endpoint of interventional device and a first centerline of interventional device (Kariv, Para 11; “The apparatus includes a localization system configured to output position and orientation (P&O) readings indicative of the P&O of a distal tip of the guidewire, which are used by a control (e.g., a processor) to determine a tip motion vector.”) (Kariv, Para 48; “A first column of data comprising a first series of P&O readings 58 that is indicative of the motion of the medical tool 26 a (e.g., distal tip when the first MPS location sensor 24 1 is located at or near the distal tip)”);
determine a second position of interventional device, the second interventional device position comprising at least a second observed endpoint and a second observed centerline (Kariv, Para 40; “the MPS 20 is configured to produce location readings of the device 26, which readings are constantly motion compensated for various movements, such as patient body movements, respiration movements, cardiac movements and the like. The control unit 12 (through dislodgement detection block 28) is configured to monitor subsequent motion-compensated location (i.e., position and orientation) readings indicating the subsequent locations of the device 26”);
determine a visual position change based on a comparison of the first observed endpoint to the second observed endpoint (Kariv, Para 58; “More specifically, the detection block 30 is configured to determine the correspondence between the position and orientation at any particular time, as compared to a recent, previous time (i.e., the correspondence between the current and previous orientation and the motion direction). Two scenarios are common: (i) a significant change in the orientation of the distal tip 68 that is not accompanied by a corresponding change in position, which can happen if the tip 68 is caught by a bifurcation (i.e., vessel branching); and (ii) a turning of the tip 68 by about 180 degrees in orientation (plus or minus a predetermined degree range) with a relatively small change in position (e.g., on the order of magnitude of the diameter of the blood vessel in which the guidewire is being navigated). When the detection block 30 detects either of these scenarios indicative of prolapse, it signals the control 12 to generate the alarm signal”);
determine an expected motion based at least in part on the drive system sensor data and a drive calibration, wherein the expected motion corresponds to drive system user input over a duration spanning the first of the plurality of images to the second of the plurality of images, the drive calibration comprising an expected movement distance corresponding to a calibration input; determine a difference between the visual position change and the expected motion (Kariv, Para 55; “A further example of a prolapse alerting situation involves a condition where there is poor correlation between the motion vector of the distal end of the guidewire (i.e., as detected by an MPS location sensor) and the motion vector of the proximal end of the guidewire (i.e., as detected by a proximal motion detecting device) or in other words where the distal and proximal ends exhibit different motion patterns. A further example involves a device that includes multiple MPS location sensors. When the movement of one sensor exhibits abnormal behavior in view of the movement of another sensor, then the apparatus determines that a prolapse condition exists”) (Kariv, Para 64; “The proximal motion detecting device 72 may be configured to detect the length of guidewire 26 b passing past the proximal motion device 72 and generate a length-indicative signal that is provided to the detection block 30. In addition, as already described above, the MPS 20 also monitors the position of the distal tip 68 (using MPS 24 1) from which the motion of (and thus the length traversed by) the distal end 68 may be determined by the detection block 30. The block 30 detects when a predetermined amount of advancement of the guidewire 26 b at the proximal end is accompanied by no more than a predetermined maximum advancement at the distal end. When the block 30 determines that this criteria has been met, it signals the control 12 to generate the alarm.”); and
cause an alert if the difference exceeds a prolapse threshold, the alert indicative of an occurrence of interventional device prolapse (Kariv, Para 24; “The control 12 is configured generally to generate an alarm signal 32 (shown as alarm block 32 in FIG. 1) in response to the predetermined criteria being satisfied indicating detection of either (1) medical tool dislodgement or (2) guidewire prolapse”) (Kariv, Para 28; “In a tool dislodgement detection embodiment, the device 26 may comprise a wide variety of medical tools 26 a (best shown diagrammatically in FIG. 3), including conventional tools such as a catheter”) (Kariv, Para 29; “In a prolapse detection embodiment (best shown diagrammatically in FIGS. 6A-6E and 7), the device 26 may comprise a guidewire 26 b or the like”).
Kariv does not clearly and explicitly disclose determining the endpoint positions and centerline positions of the interventional device within the plurality of images.
In an analogous surgical navigation field of endeavor Bell discloses determining an endpoint and centerline position of an interventional device (Bell, Para 9; “e medical image, a distal tip of the medical instrument, and based on the detected distal tip of the medical instrument, determine a two-dimensional position of the distal tip of the medical instrument within a plane of the two-dimensional medical image; (i) wherein detecting the distal tip of the medical instrument comprises determining, based on the medical image, a centerline of the distal portion of the medical instrument, and determining an endpoint for the centerline”) (Bell, Para 11; “detecting, within the medical image, a distal tip of the medical instrument, and based on the detected distal tip of the medical instrument, determining a two-dimensional position of the distal tip of the medical instrument within a plane of the two-dimensional medical image; (i) wherein detecting the distal tip of the medical instrument comprises determining, based on the medical image, a centerline of the distal portion of the medical instrument, and determining an endpoint for the centerline; (j) detecting, within the medical image, a portion of the medical instrument, and based on the detected distal portion of the medical instrument, determine a heading of the medical instrument within a plane of the two-dimensional medical image; (k) wherein determining the heading of the medical instrument comprises determining, based on the medical image, a centerline of the distal portion of the medical instrument, and determining an endpoint for the centerline, and determining a vector extending from the endpoint, the vector being colinear with a distal portion of the centerline; (l) wherein the medical instrument comprises an endoluminal medical instrument”) based on a plurality of images (Bell, Para 110; “the comparison may be performed at discrete steps. In some embodiments, the comparison may be performed continuously”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kariv to include determining the endpoint positions and centerline positions of the interventional device within the plurality of images in order to allow for more optimal placement of medical equipment as taught by Bell.
Such a modification amounts to the mere combination of known prior art parts to yield predictable results, which has previously been held to involve no more than routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 3, Kariv as modified by Bell above discloses all of the limitations of claim 1 as discussed above.
Kariv further discloses wherein the alert comprises a user graphic (Kariv, Para 47; “The alarm block 32 may take any one or more different alerting or alarming mechanisms known in the art. For example, the alarm 32 may comprise a visual indication, an audible indication (i.e., either verbal or non-verbal), a tactile indication or a combination of one or more of the foregoing indications”).
Regarding claim 5, Kariv as modified by Bell above discloses all of the limitations of claim 1 as discussed above.
Kariv further discloses wherein the alert comprises haptic feedback to a controller of the drive system (Kariv, Para 47; “The alarm block 32 may take any one or more different alerting or alarming mechanisms known in the art. For example, the alarm 32 may comprise a visual indication, an audible indication (i.e., either verbal or non-verbal), a tactile indication or a combination of one or more of the foregoing indications”).
Regarding claim 6, Kariv as modified by Bell above discloses all of the limitations of claim 1 as discussed above.
Kariv further discloses the interventional device drive system (Kariv, Para 64; “The proximal motion detecting device 72 may be configured to detect the length of guidewire 26 b passing past the proximal motion device 72 and generate a length-indicative signal that is provided to the detection block 30”) (Kariv, Para 34; “a second MPS location sensor 24 2 is coupled at another location more proximal of sensor 24 1 and may be at the proximal end of the tool 26 a”).
Regarding claim 7, Kariv as modified by Bell above discloses all of the limitations of claim 1 as discussed above.
Kariv further discloses the imaging system (Kariv, Para 25; “The image data in the database 18 may comprise known image types including […] a plurality of related two-dimensional images obtained in real-time from an image acquisition device (e.g., fluoroscopic images from an x-ray imaging apparatus, such as that shown in exemplary fashion in FIG. 2) wherein the image database acts as a buffer (live fluoroscopy)”).
Regarding claim 8, Kariv as modified by Bell above discloses all of the limitations of claim 1 as discussed above.
Kariv as modified by Bell above further discloses wherein the interventional device comprises a guidewire and the first observed endpoint and second observed endpoint correspond to an endpoint of the guidewire in the first and second of the plurality of images (Kariv, Para 24; “The control 12 is configured generally to generate an alarm signal 32 (shown as alarm block 32 in FIG. 1) in response to the predetermined criteria being satisfied indicating detection of either (1) medical tool dislodgement or (2) guidewire prolapse”) (Kariv, Para 28; “In a tool dislodgement detection embodiment, the device 26 may comprise a wide variety of medical tools 26 a (best shown diagrammatically in FIG. 3), including conventional tools such as a catheter”) (Kariv, Para 29; “In a prolapse detection embodiment (best shown diagrammatically in FIGS. 6A-6E and 7), the device 26 may comprise a guidewire 26 b or the like”).
Kariv as modified by Bell above is interpreted as disclosing this limitation in the claim because Kariv is modified by Bell to detect the endpoint and centerline using images.
Regarding claim 9, Kariv as modified by Bell above discloses all of the limitations of claim 1 as discussed above.
Kariv as modified by Bell above further discloses wherein the interventional device comprises a catheter and wherein the first endpoint and second endpoint correspond to an endpoint of the catheter in the first and second of the plurality of images (Kariv, Para 24; “The control 12 is configured generally to generate an alarm signal 32 (shown as alarm block 32 in FIG. 1) in response to the predetermined criteria being satisfied indicating detection of either (1) medical tool dislodgement or (2) guidewire prolapse”) (Kariv, Para 28; “In a tool dislodgement detection embodiment, the device 26 may comprise a wide variety of medical tools 26 a (best shown diagrammatically in FIG. 3), including conventional tools such as a catheter”) (Kariv, Para 29; “In a prolapse detection embodiment (best shown diagrammatically in FIGS. 6A-6E and 7), the device 26 may comprise a guidewire 26 b or the like”).
Kariv as modified by Bell above is interpreted as disclosing this limitation in the claim because Kariv is modified by Bell to detect the endpoint and centerline using images.
Regarding claim 10, Kariv as modified by Bell above discloses all of the limitations of claim 1 as discussed above.
Kariv further discloses wherein the one or more processors is configured to execute programming for computer vision analysis of at least some of the plurality of images (Kariv, Para 62; “The control 12 may be further configured to determine the predetermined threshold based on an image or electroanatomical model of the region of interest that contains the distal tip 68. Moreover, such an image may be obtained through fluoroscopy”).
Regarding claim 11, Kariv as modified by Bell above discloses all of the limitations of claim 1 as discussed above.
Kariv further discloses wherein the one or more processors are further configured to: compare the first centerline to the second centerline to determine a curvature change; (Kariv, Para 61-62; “FIG. 6D is a further example of a prolapse condition of the guidewire tip 68 (e.g., the guidewire tip being turned-around in a blood vessel). The motion vector 70A represents the immediately previous motion vector while the motion vector 70B is the current motion vector. […] The direction of the motion vector 70B is substantially opposite that of the motion vector 70A or in other words the tip 68 has undergone about a 180 degree change in orientation.”) and cause a buckling alert if the curvature change exceeds a curvature threshold (Kariv, Para 58; “More specifically, the detection block 30 is configured to determine the correspondence between the position and orientation at any particular time, as compared to a recent, previous time (i.e., the correspondence between the current and previous orientation and the motion direction). Two scenarios are common: (i) a significant change in the orientation of the distal tip 68 that is not accompanied by a corresponding change in position, which can happen if the tip 68 is caught by a bifurcation (i.e., vessel branching); and (ii) a turning of the tip 68 by about 180 degrees in orientation (plus or minus a predetermined degree range) with a relatively small change in position (e.g., on the order of magnitude of the diameter of the blood vessel in which the guidewire is being navigated). When the detection block 30 detects either of these scenarios indicative of prolapse, it signals the control 12 to generate the alarm signal.”).
Regarding claim 17, Kariv as modified by Bell above discloses all of the limitations of claim 13 as discussed above.
Kariv further discloses wherein the interventional device comprises a guidewire and wherein the first observed endpoint and second observed endpoint correspond to an endpoint of the guidewire in the first and second of the plurality of images or wherein the interventional device comprises a catheter and wherein the first observed endpoint and second observed endpoint correspond to an endpoint of the catheter in the first and second of the plurality of images (Kariv, Para 24; “The control 12 is configured generally to generate an alarm signal 32 (shown as alarm block 32 in FIG. 1) in response to the predetermined criteria being satisfied indicating detection of either (1) medical tool dislodgement or (2) guidewire prolapse”) (Kariv, Para 28; “In a tool dislodgement detection embodiment, the device 26 may comprise a wide variety of medical tools 26 a (best shown diagrammatically in FIG. 3), including conventional tools such as a catheter”) (Kariv, Para 29; “In a prolapse detection embodiment (best shown diagrammatically in FIGS. 6A-6E and 7), the device 26 may comprise a guidewire 26 b or the like”).
Kariv as modified by Bell above is interpreted as disclosing this limitation in the claim because Kariv is modified by Bell to detect the endpoint and centerline using images.
Regarding claim 18, Kariv as modified by Bell above discloses all of the limitations of claim 13 as discussed above.
Kariv further discloses comparing the first centerline to the second centerline to determine a curvature change (Kariv, Para 61-62; “FIG. 6D is a further example of a prolapse condition of the guidewire tip 68 (e.g., the guidewire tip being turned-around in a blood vessel). The motion vector 70A represents the immediately previous motion vector while the motion vector 70B is the current motion vector. […] The direction of the motion vector 70B is substantially opposite that of the motion vector 70A or in other words the tip 68 has undergone about a 180 degree change in orientation.”); and causing a buckling alert if the curvature change exceeds a curvature threshold (Kariv, Para 58; “More specifically, the detection block 30 is configured to determine the correspondence between the position and orientation at any particular time, as compared to a recent, previous time (i.e., the correspondence between the current and previous orientation and the motion direction). Two scenarios are common: (i) a significant change in the orientation of the distal tip 68 that is not accompanied by a corresponding change in position, which can happen if the tip 68 is caught by a bifurcation (i.e., vessel branching); and (ii) a turning of the tip 68 by about 180 degrees in orientation (plus or minus a predetermined degree range) with a relatively small change in position (e.g., on the order of magnitude of the diameter of the blood vessel in which the guidewire is being navigated). When the detection block 30 detects either of these scenarios indicative of prolapse, it signals the control 12 to generate the alarm signal.”).
Regarding claim 19, Kariv as modified by Bell above discloses all of the limitations of claim 13 as discussed above.
Kariv further discloses wherein the alert comprises haptic feedback to a controller of the drive system (Kariv, Para 47; “The alarm block 32 may take any one or more different alerting or alarming mechanisms known in the art. For example, the alarm 32 may comprise a visual indication, an audible indication (i.e., either verbal or non-verbal), a tactile indication or a combination of one or more of the foregoing indications”).
Claims 4 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kariv and Bell as applied to claims 3 and 13 above, and further in view of Sims (US20220401143).
Regarding claim 4, Kariv as modified by Bell above discloses all of the limitations of claim 3 as discussed above.
Kariv does not clearly and explicitly disclose wherein the user graphic comprises a prompt, wherein the prompt requires user input to allow further input to the interventional device drive system.
In an analogous surgical robot field of endeavor Sims discloses an alert prompt, wherein the alert prompt requires user input to allow further input to an interventional device if there is a detected error (Sims, Para 11; “Depending upon the error, the supply of energy may be stopped or may be allowed to continue as-is or only after modification of energy-delivery, the instrument, etc. (automatically or by the user)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kariv wherein the user graphic comprises a prompt, wherein the prompt requires user input to allow further input to the interventional device drive system in order to facilitate safer operation of the device as taught by Sims (Sims, Para 2 and 55).
Regarding claim 15, Kariv as modified by Bell above discloses all of the limitations of claim 13 as discussed above.
Kariv does not clearly and explicitly disclose blocking user input to a interventional device drive system if the difference between the visual position change and the expected motion exceeds the prolapse threshold.
In an analogous surgical robot field of endeavor Sims discloses blocking user input to further input to an interventional device if there is a detected error (Sims, Para 11; “Depending upon the error, the supply of energy may be stopped or may be allowed to continue as-is or only after modification of energy-delivery, the instrument, etc. (automatically or by the user)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kariv to include blocking user input to a interventional device drive system if the difference between the visual position change and the expected motion exceeds the prolapse threshold in order to facilitate safer operation of the device as taught by Sims (Sims, Para 2 and 55).
Regarding claim 16, Kariv as modified by Bell above discloses all of the limitations of claim 15 as discussed above.
Kariv does not clearly and explicitly disclose wherein the alert comprises a prompt, and wherein the prompt requires user input to allow further input to the interventional device drive system.
In an analogous surgical robot field of endeavor Sims discloses an alert prompt, wherein the alert prompt requires user input to allow further input to an interventional device if there is a detected error (Sims, Para 11; “Depending upon the error, the supply of energy may be stopped or may be allowed to continue as-is or only after modification of energy-delivery, the instrument, etc. (automatically or by the user)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kariv wherein the alert comprises a prompt, and wherein the prompt requires user input to allow further input to the interventional device drive systemin order to facilitate safer operation of the device as taught by Sims (Sims, Para 2 and 55).
Claims 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kariv and Bell as applied to claims 1 and 13 above, and further in view of Lenker et al., (US5860923, hereafter Lenker).
Regarding claims 12 and 20, Kariv as modified by Bell above discloses all of the limitations of claims 1 and 13 as discussed above.
Kariv does not clearly and explicitly disclose wherein at least some of the plurality of images comprise an image of a radio-opaque portion of the interventional device, and wherein the one or more processors are configured to validate at least one of the determined first position and second position against a position of the radio-opaque portion of the interventional device.
In an analogous surgical tracking field of endeavor Lenker a plurality of images comprise an image of a radio-opaque portion of an interventional device, and validating an interventional device position against a position of the radio-opaque portion of the interventional device (Lenker, Col 6, lines 17-34; “Providing calibration marks 30 near the marker 26 (see FIG. 2) allows for direct visual reading of the axial distance between the radiopaque markers 18, 26 from the distal end of the catheter 10, while providing calibration marks 30 at the proximal end 22 allows for direct visual reading of the axial distance between the radiopaque markers 18, 26 from a proximal end of the catheter 10. Inclusion of the calibration marks 30 at the proximal end 22 is advantageous in that the axial distance between the markers 18, 26 can be determined while the catheter 10 is within a patient because the proximal end 22 remains outside the patient at all times. To visually read the marks 30 near the distal end 24 while the catheter remains in the patient, the marks can be radiopaque and visualized fluoroscopically. Alternatively, the catheter 10 can be removed from the patient to visualize the marks 30 near the distal end 24”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kariv wherein at least some of the plurality of images comprise an image of a radio-opaque portion of the interventional device, and wherein the one or more processors are configured to validate at least one of the determined first position and second position against a position of the radio-opaque portion of the interventional device in order to more accurately determine distance as taught by Lenker (Lenker, Col 2, lines 35-44).
Allowable Subject Matter
Claims 2 and 14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art does not disclose nor reasonably suggest the limitations set forth in claims 2 and 14. Specifically, the prior art does not disclose a method of robotically controlling an interventional device, the method comprising: receiving a plurality of images from an imaging system and drive system sensor data from an interventional device drive system; determining a first position of the interventional device using a first of the plurality of images, the first position comprising at least a first observed endpoint of the interventional device within the first of the plurality of images and a first observed centerline; determining a second position of the interventional device using a second of the plurality of images, the second position comprising at least a second observed endpoint of the interventional device within the second of the plurality of images and a second observed centerline of the interventional device within the second of the plurality of images; determining a visual position change based on a comparison of the first endpoint to the second endpoint; determining an expected motion based at least in part on the drive system sensor data and a drive calibration, wherein the expected motion corresponds to drive system user input over a duration spanning the first of the plurality of images to the second of the plurality of images, the drive calibration comprising an expected movement distance corresponding to a calibration input; determining a difference between the visual position change and the expected motion; and causing an alert if the difference between the visual position change and the expected motion exceeds a prolapse threshold, the alert indicative of occurrence of interventional device prolapse, wherein the prolapse threshold is 5%.
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 John Li whose telephone number is (313)446-4916. The examiner can normally be reached Monday to Thursday; 5:30 AM to 3:30 PM Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN D LI/Primary Examiner, Art Unit 3798
Prosecution Insights