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 Arguments
Applicant’s arguments with respect to claim(s) 1, 4-14, 16-17, and 19-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 4, 6-13, 16-17, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glossop (US 2007/0055128 A1).
Regarding Claim 1, Glossop discloses A system, comprising: an elongate probe configured to be inserted into a working channel of an elongate instrument [Glossop: ¶ [0022]: If a tracked elongated member is dragged through a channel of the endoscope or other instrument, the locus of points gathered as the position of sensor elements in the tracked member are sampled prescribe a shape that is the same as the shape of the endoscope or other instrument. This information may be used to assist in the medical procedure… In some embodiments, multiple sensor elements may be.. moved along the endoscope or other instrument to determine its path]; the elongate probe including a plurality of position sensors distributed along its length [Glossop: ¶ [0022]: multiple sensor elements]; and control circuitry configured to: determine positions and orientations of each of the plurality of position sensors along the length of the elongate probe [Glossop: ¶ [0026]: Acquisition of data in patient space can be performed by dragging a tracked endoscope or other instrument back through the anatomy of the patient (e.g., dragging it back through the colon) or a tracked instrument back through the working channel of the endoscope (or the working channel of a catheter or other instrument inserted into the patient's anatomy) while the position sensing system gathers/samples data points regarding the position and/or orientation of the sensor elements on the tracked instrument in the frame of reference/coordinate system of the position sensing system]; determine a curve that passes through the positions of each of the plurality of position sensors along the length of the elongated probe based at least in part on the orientations of the plurality of position sensors while the elongate probe is at least partially inserted within the working channel of the elongate instrument [Glossop: ¶ [0022]; [0043]; and [0070]: when multiple sensor elements are located along a portion of the endoscope), and thus its "shape" within the anatomy of the patient, in the frame of reference of position sensing system 407. Sensor elements in endoscope 403 may be used instead of, or in addition to, an elongated instrument 421 with one or more sensor elements included therein]; and estimate a shape of the elongate instrument based on the curve [Glossop: ¶ [0070]: shape].
Regarding Claim 4, Glossop discloses all the limitations of Claim 1, and is analyzed as previously discussed with respect to that claim.
Furthermore, Glossop discloses wherein the control circuitry is further configured to render a representation of at least a portion of the elongate instrument on a graphical interface, wherein the representation of the at least a portion of the elongate instrument has a shape that is based on the estimated shape of the elongate instrument [Glossop: ¶ [0010]-[0011]; and ¶ [0034]: the invention may include a navigation step in which the endoscope or other instrument equipped with sensor elements is tracked by the position sensing system. As the endoscope is moved through the anatomy to inspect its interior, the position of the endoscope or tracked instrument may be sampled in the reference frame of the position sensing system. The locations and orientations determined by the position sensing system are sent to the control unit, which creates a real-time or near real-time display of the motion of the tracked instrument relative to the lesions or other points of interest as identified in the image space. The display is enabled by the transformation matrix produced by the registration. This display is used, for example, for image-guided navigation of the endoscope in an attempt to locate suspect lesions or other items of interest using the optics of the endoscope].
Regarding Claim 6, Glossop discloses all the limitations of Claim 1, and is analyzed as previously discussed with respect to that claim.
Furthermore, Glossop discloses wherein the control circuitry is further configured to determine sensor link lengths associated with the plurality of position sensors [Glossop: ¶ [0038]: the sensor elements on a trackable guidewire act simply as a distance measurement device to determine the location of the endoscope relative to a known location. In this embodiment, the relative location of all suspect lesions are calculated relative to each other and landmarks within the anatomy. As each is examined, the location is stored and the distance to the next location of interest is calculated] (As best understood, instant application ¶ [0007] recites “the sensor link lengths spanning lengths of the elongate instrument between pairs of the plurality of position sensors”, therefore the distance between the position sensors is taken to be the “link lengths associated” therewith. The position sensor knowing their position relative to each other therefore know the distance therebetween).
Regarding Claim 7, Glossop discloses all the limitations of Claim 6, and is analyzed as previously discussed with respect to that claim.
Furthermore, Glossop discloses wherein the curve is based at least in part on the sensor link lengths [Glossop: ¶ [0043]].
Regarding Claim 8, Glossop discloses all the limitations of Claim 7, and is analyzed as previously discussed with respect to that claim.
Furthermore, Glossop discloses wherein at least one of the sensor link lengths spans between non-adjacent sensors of the plurality of position sensors [Glossop: ¶ [0043]; where the position sensors knowing their position relative to one another contain a known span between each and every sensor].
Regarding Claim 9, Glossop discloses all the limitations of Claim 7, and is analyzed as previously discussed with respect to that claim.
Furthermore, Glossop discloses wherein the control circuitry is further configured to re-configure the sensor link lengths during operation of the elongate instrument [Glossop: ¶ [0043] (“re-configure the sensor link lengths during operation” appears to be disclosed in Glossop tracking the sensor elements relative to each other and adjusting the shape and curve estimates based on the updated/re-configured data)].
Regarding Claim 10, Glossop discloses a system, comprising: control circuitry configured to communicatively couple to an elongate probe having a plurality of position sensors distributed along its length [Glossop: ¶ [0022]]; wherein the control circuitry is configured to: determine relative positions of the plurality of position sensors with respect to the length of the elongate probe [Glossop: ¶ [0022]; and [0043]]; determine sensor link lengths associated with the plurality of position sensors while the elongate probe is at least partially inserted within a working channel of an endoscope, the sensor link lengths spanning lengths of the elongate probe between pairs of the plurality of position sensors [Glossop: ¶ [0022]]; and generate a curve [Glossop: ¶ [0022]; [0043]; and [0070]] that represents a shape of the elongate instrument based on the sensor link lengths [Glossop: ¶ [0070]].
Regarding Claim 11, Glossop discloses all the limitations of Claim 10, and is analyzed as previously discussed with respect to that claim.
Furthermore, Glossop discloses wherein the determining the relative positions of the plurality of position sensors and the determining the sensor link lengths involves accessing pre-determined parameters associated with the elongate instrument [Glossop: ¶ [0031]: In some embodiments, registration may be accomplished using techniques other than or in addition to the dragback technique described above. For example, in one embodiment, a "landmark-based" method may be used that includes the identification of "fiducials" present in both pre-operative images and identified during the examination by, for example, touching them with a tracked instrument or imaging them with a tracked calibrated ultrasound transducer to determine their location in patient space].
Regarding Claim 12, Glossop discloses all the limitations of Claim 10, and is analyzed as previously discussed with respect to that claim.
Furthermore, Glossop discloses wherein the control circuitry is further configured to: determine current positions of the plurality of position sensors relative to a coordinate system; and determine current orientations of the plurality of position sensors relative to the coordinate system; wherein the curve is based on the current positions and the current orientations [Glossop: ¶ [0023]: To conduct or assist image-guided surgery, it is desirable to register or match the coordinate system of the position sensing system to the coordinate system belonging to the pre-operative image space, intra-operative image space, or a co-registered combination of the pre and intra-operative images. One way of facilitating this is by acquiring a plurality of points in position sensor space or "patient space" (i.e., the coordinate system/frame of reference intrinsic to the position sensing system) and mathematically matching them to the same points in image space].
Regarding Claim 13, Glossop discloses all the limitations of Claim 12, and is analyzed as previously discussed with respect to that claim.
Furthermore, Glossop discloses wherein the control circuitry is further configured to: generate one or more curve segments based on one or more of the current orientations; and compare lengths of the one or more curve segments to respective ones of the sensor link lengths; wherein the curve is based on the comparing [Glossop: ¶ [0026] Acquisition of data in patient space can be performed by dragging a tracked endoscope or other instrument back through the anatomy of the patient (e.g., dragging it back through the colon) or a tracked instrument back through the working channel of the endoscope (or the working channel of a catheter or other instrument inserted into the patient's anatomy) while the position sensing system gathers/samples data points regarding the position and/or orientation of the sensor elements on the tracked instrument in the frame of reference/coordinate system of the position sensing system].
Regarding Claim 16, Glossop discloses all the limitations of Claim 10, and is analyzed as previously discussed with respect to that claim.
Furthermore, Glossop discloses wherein the determining the sensor link lengths is performed in real-time in connection with the determining the curve [Glossop: ¶ [0034]: The locations and orientations determined by the position sensing system are sent to the control unit, which creates a real-time or near real-time display of the motion of the tracked instrument relative to the lesions or other points of interest as identified in the image space].
Regarding Claim 17, Glossop discloses a method comprising: inserting an elongate probe at least partially into a working channel of an elongate instrument, the elongate probe including a plurality of position sensors distributed along its length [Glossop: ¶ [0022]; [0043]] determining positions of the plurality of position sensors along the length of the elongate probe relative to a coordinate system [Glossop: ¶ [0026]]; determining orientations of the plurality of position sensors along the length of the elongate probe relative to the coordinate system [Glossop: ¶ [0026]]; and generating a curve that passes through the positions of each of the plurality of position sensors along the length of the elongate probe based at least in part on the orientations of the plurality of position sensors while the elongate probe is at least partially inserted within the working channel of the elongate instrument [Glossop: ¶ [0070]].
Regarding Claim 19, Glossop discloses all the limitations of Claim 17, and is analyzed as previously discussed with respect to that claim.
Furthermore, Glossop discloses further comprising generating graphical interface data representing: an anatomical model [Glossop: ¶ [0084] If two representations of the endoscope's path from two different coordinate systems are to resolve the image space path of endoscope 403 (e.g., an assumed path calculated using pre-operative image data and the actual path observed from the intra-operative images), the two representations themselves must first be "matched" or "registered." This registration may utilize 2D-3D or 3D-3D co-registration techniques; ¶ [0102]: As each lesion is encountered, its position is sampled using a tracked instrument and used to calculate a transformation matrix. In some embodiments, only the nearest candidate lesions to the immediate endoscope location can be used to calculate a local registration, since they are most representative of the local anatomy] and a representation of a segment of the elongate instrument conforming to a shape that matches the curve within the anatomical model [Glossop: ¶ [0034; The locations and orientations determined by the position sensing system are sent to the control unit, which creates a real-time or near real-time display of the motion of the tracked instrument relative to the lesions or other points of interest as identified in the image space. The display is enabled by the transformation matrix produced by the registration. This display is used, for example, for image-guided navigation of the endoscope in an attempt to locate suspect lesions or other items of interest using the optics of the endoscope].
Regarding Claim 20, Glossop discloses all the limitations of Claim 17, and is analyzed as previously discussed with respect to that claim.
Furthermore, Glossop discloses further comprising determining sensor link segments associated with the plurality of position sensors, wherein the curve is based on lengths of the sensor link segments [Glossop: ¶ [0038]: the sensor elements on a trackable guidewire act simply as a distance measurement device to determine the location of the endoscope relative to a known location. In this embodiment, the relative location of all suspect lesions are calculated relative to each other and landmarks within the anatomy. As each is examined, the location is stored and the distance to the next location of interest is calculated].
Claim Rejections - 35 USC § 103
Claim(s) 5 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glossop as applied to claims 1 and 13 above, and further in view of Malinin et al. (US 2016/0367168 A1).
Regarding Claim 5, Glossop disclose(s) all the limitations of Claim 1, and is/are analyzed as previously discussed with respect to that claim.
Glossop may not explicitly disclose wherein the curve is a third-degree Hermite spline.
However, Malinin discloses wherein the curve is a third-degree Hermite spline [Malinin: ¶ [0040]: In some embodiments, determining the magnetic location of the electrodes 30-4, 30-5, 30-6 in the magnetic based coordinate system includes determining a Hermite curve between two five degree-of-freedom magnetic position sensors 84-1, 84-2 disposed in a distal end and a proximal end of the catheter 86 based on a position and orientation of the two five degree-of-freedom magnetic position sensors and a known distance between electrodes 30-4, 30-5, 30-6 disposed on the catheter 86. For instance, based on the position and orientation of each of the magnetic position sensors 84-1, 84-2, a vector 88-1, 88-2 for each of the magnetic position sensors 84-1, 84-2 can be determined in the magnetic coordinate system. In some embodiments, a Hermite curve 90 can be computed between the magnetic position sensors 84-1, 84-2 (e.g., and the vectors 88-1, 88-2). The Hermite curve 90 can be computed based on the startpoint of the curve (e.g., proximal end of vector 88-2) and the direction that the curve leaves the startpoint (e.g., slope of vector 88-2) and the endpoint of the curve (e.g., distal end of vector 88-1) and the direction that the curve meets the endpoint (e.g., slope of vector 88-1)].
It would have been obvious to one having ordinary skill in the art before the effective filing date to combine the equation of Malinin with the processing of Glossop in order to provide data for systems set up to utilize specific equation, improving usability.
Regarding Claim 14, Glossop disclose(s) all the limitations of Claim 13, and is/are analyzed as previously discussed with respect to that claim.
Glossop may not explicitly disclose wherein the control circuitry is further configured to: determine a total length of the curve; compare the total length of the curve to a predetermined length of the elongate instrument; and determine that the curve is a best-fit curve based on the comparing the lengths of the one or more curve segments and the comparing the total length of the curve.
However, Malinin discloses wherein the control circuitry is further configured to: determine a total length of the curve; compare the total length of the curve to a predetermined length of the elongate instrument; and determine that the curve is a best-fit curve based on the comparing the lengths of the one or more curve segments and the comparing the total length of the curve [Malinin: ¶ [0044]: For example, the portion of the catheter 102 between the magnetic position sensors 100-1, 100-2 can be deflected and a polynomial function can be determined, which best fits the radius of curvature of the catheter over various states of deflection].
Claim(s) 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glossop as applied to claims 1 and 13 above, and further in view of Adebar (US 2022/0143366 A1)
Regarding Claims 21-24, Glossop disclose(s) all the limitations of Claims 1, 10, and 17, and is/are analyzed as previously discussed with respect to that claim.
Glossop may not explicitly disclose wherein the control circuitry is further configured to detect a buckling of the elongate instrument and a location of the buckling along a length of the elongate instrument based on the curve.
However, Adebar discloses wherein the control circuitry is further configured to detect a buckling of the elongate instrument and a location of the buckling along a length of the elongate instrument based on the curve [Adebar: [0082] At a process 810, the control system 112 determines a state of a system configuration based on the location (determined at process 808) of the portion of the elongate instrument along a length of the elongate instrument. In some embodiments, when the location of the portion of the medical instrument 104 that exceeds the threshold difference between the models 512, 500 is at a proximal portion of the medical instrument 104, the state of the system configuration includes a buckled state of the medical instrument 104. In some embodiments, determining that the location of the portion of the medical instrument 104 that exceeds the threshold difference between the models 512, 500 is at the proximal portion of the medical instrument 104 is a factor that weighs in favor, in combination with other detected deviations which are characterized as high factor probability indicators of buckling, of a determination that the deviation can be attributed to instrument buckling].
It would have been obvious to one having ordinary skill in the art before the effective filing date to combine the buckling detection of Adebar with the processing of Glossop in order to provide improved user situational awareness.
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 JONATHAN R MESSMORE whose telephone number is (571)272-2773. The examiner can normally be reached Monday-Friday 9-5 EST/EDT.
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/JONATHAN R MESSMORE/Primary Examiner, Art Unit 2482