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 § 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.
Claim 3 is 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.
Claim 3 recites the limitation “localization data from the sensor system”. It is unclear if the localization data is the same as or different from the point cloud data. If they are the same, it is unclear why the limitations are listed with separate modifiers and if they are intended to be different, it is unclear what localization data from the sensor system is provided other than the point cloud data. For examination purposes, it has been interpreted to mean any localization data and may be the same as the point cloud data, however, clarification is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9 and 17-19 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Ayvaliet al. (US 20210298590 A1 and cited in applicant’s IDS filed 05/01/2024)
Regarding claim 1,
Ayvali discloses a method for providing guidance for percutaneous access to a target within an anatomic structure, the method comprising:
Receiving point cloud data ([0179] which discloses a position of a medical device can be represented with coordinates of a point/point-set within a coordinate system (e.g. one or more X, Y, Z coordinates) from a sensor system ([0105] which discloses the medical instrument (e.g., scope) 440 includes a sensor that is configured to generate and/or send sensor position data to another device. The sensor position data can indicate a position and/or orientation of the medical instrument 440 (e.g., the distal end 442 thereof) and/or can be used to determine/infer a position/orientation of the medical instrument. For example, a sensor (sometimes referred to as a “position sensor”) can include an electromagnetic (EM) sensor with a coil of conductive material, or other form/embodiment of an antenna. [0084] which discloses For example, the localization component 314 can process input data (e.g., sensor data from a medical instrument, model data regarding anatomy of a patient, position data of a patient, pre-operative data, robotic command and/or kinematics data, etc.) to generate position/orientation data 320 for one or more medical instruments) coupled to an internal instrument (at least fig. 4 (440) and corresponding disclosure in at least [0105]) as the internal instrument is moved within the anatomic structure ([0197] which discloses while driving the scope to the target papilla/calyx, a plurality of positions associated with the distal end portion of the scope may be tagged/recorded along the path to provide a scatterplot-type mapping of at least a portion of the calyx network (e.g., the target calyx and/or associated infundibulum);
Generating a 3D model (at least figs. 16 (1600) /17 (1700) and corresponding disclosure in at least [0197]-[0198]) including the anatomic structure, wherein the 3D model is based at least in part on the point cloud data ([0197] which discloses a plurality of positions associated with the distal end portion of the scope may be tagged/recorded along the path to provide a scatterplot-type mapping and a gaussian interpolation may be implemented to generate the three-dimensional surface map 1700 as disclosed in [0198]) ;
Receiving information for identifying a substructure within the 3D anatomic model, wherein the substructure provides access to the target ([0199] which discloses in some embodiments, as shown in FIG. 15, circular motions may be effected in the scope to generate a sufficient position plot of the target calyx, wherein the calyx map to be formed therefrom. The calyx orientation 1715 can be estimated from the calyx map 1700, wherein such trajectories 1715 can provide a path along which scope/papilla offset may be projected/determined. This may allow the target position to be updated more robustly for cases where the scope heading changes with respect to the calyx, infundibulum, and/or papilla axis due to tissue deformation during needle insertion. Depending on the particular procedure, it may not be necessary to map out the entire calyx network of the kidney for the purpose of percutaneous access targeting. For example, only the calyx associated with the target papilla may be mapped in some implementations. In some implementations, multiple calyces may be mapped to provide increased spatial information/mapping see also [0114]-[0115] which disclose locating a kidney stone using an image-capturing device and identifying a target papilla that is exposed within a target Calyx through which access to the kidney stone may be achieved);
Determining an entry point to the substructure ([0117] which discloses the process 500 involves tagging/recording the position of the exposed papilla 579 within the target calyx 579 through which the desired access is to be achieved. See also [0116] which discloses by targeting entry in the area of the axial center of the calyx 575, major arteries and/or other blood vessels can be avoided in some instances, [0009] which discloses some embodiments involve the presentation of one or more icons representing a projected needle entry point into the target anatomical feature (e.g., papilla), and [0177] which discloses For example, where the projected needle entry point into the target calyx and/or through the target papilla 914 is outside of the field of view 952 of the scope camera, the interface feature(s) 956 can notify the physician 5 of the direction the scope 92 can be moved to bring the projected needle entry point into the camera view 952);
Determining an approach path through the entry ([0176] which discloses The control system 50 can include control circuitry configured to determine a target trajectory 902 for inserting the needle 17 to assist the physician 5 in reaching the target location (e.g., the papilla 914). See also [0092] which discloses target/trajectory component 316 can also be configured to determine a target trajectory for a medical instrument or another object. A target trajectory can represent a desired path for accessing a target location and/or anatomical feature. A target trajectory can be determined based on a variety of information, such as a position of a medical instrument(s) (e.g., a needle, a scope, etc.), a target location within the human anatomy, a position and/or orientation of a patient, the anatomy of the patient (e.g., the location of organs within the patient relative to the target location), and so on) ; and
Providing a graphical representation of the approach path (See at least fig. 13 (902) and corresponding disclosure in at least [0176]. See also [0092] which discloses in examples, a physician can analyze images or models of the human anatomy and provide input to designate a target trajectory, such as by drawing a line on an image of the internal anatomy of a patient. In some embodiments, the target/trajectory component 316 can calculate a target trajectory initially and/or update the target trajectory throughout the procedure).
Regarding claim 2,
Ayvali further discloses wherein the approach path is based at least in part on geometry of the substructure ([0175] which discloses the control system 50 can include control circuitry configured to determine a target trajectory 902 for inserting the needle 17 to assist the physician 5 in reaching the target location (e.g., the papilla 914). The target trajectory 902 can represent a desired path for accessing the target location. The target trajectory 902 can be determined based on a position of one or more medical instruments (e.g., the needle 17, the scope 92, etc.), a target location within the patient anatomy, a position and/or orientation of the patient 13, the anatomy of the patient (e.g., the location of organs within the patient relative to the target location), and so on. In some implementations, the target trajectory 902 represents a straight line that passes through the papilla 914 and the point of the needle 17. The trajectory may be generally in-line with the axis of the infundibulum associated with the target calyx. Examiner thus notes that the approach path is therefore based at least in part on geometry (e.g. tubular shape) and axis thereof of the substructure)
Regarding claim 3,
Ayvali further discloses wherein generating the 3D model further includes generating a representation of the target at a location within 3D model, and wherein the location of the target within the 3D model is based at least in part on localization data from the sensor system as the internal instrument is pointed toward the target (see at least figs. 16 (1600) and 17 (1700) and [0197] which discloses a Gaussian interpolation may be implemented along the reported trajectory, or portion thereof, within a target calyx 1612 and/or associated infundibulum 1613, wherein such interpolation is used to generate a surface estimate with respect to at least a portion of the calyx network).
Regarding claim 4,
Ayvali further discloses wherein the information for identifying the substructure includes user input for selection of the substructure ([0118] which discloses In order to record the position of the papilla 579, the scope 540 may be advanced to physically touch/contact the target papilla 579, as shown by the advanced scope tip 543, in connection with which such contact position may be identified and/or otherwise indicated as the target position by the scope 540 and/or operator, a user input device (e.g., pendant) can be used to inform the system that contact has been made with the target anatomical feature. See also [0131] which discloses the user may provide input to notify the relevant control/medical system of the feature-contact position of the target anatomical feature by tagging/registering the position of the exposed face of the target anatomical feature (e.g., papilla face exposed within the target calyx) in some manner. Such tagging may be implemented through provision of user input in some manner or may be substantially automatic based on perceived tissue contact, or the like.).
Regarding claim 5,
Ayvali further discloses wherein the information for identifying the substructure includes position and orientation of the substructure relative to the target ([0199] which discloses in some embodiments, as shown in FIG. 15, circular motions may be effected in the scope to generate a sufficient position plot of the target calyx, wherein the calyx map to be formed therefrom. The calyx orientation 1715 can be estimated from the calyx map 1700, wherein such trajectories 1715 can provide a path along which scope/papilla offset may be projected/determined. This may allow the target position to be updated more robustly for cases where the scope heading changes with respect to the calyx, infundibulum, and/or papilla axis due to tissue deformation during needle insertion. Depending on the particular procedure, it may not be necessary to map out the entire calyx network of the kidney for the purpose of percutaneous access targeting. For example, only the calyx associated with the target papilla may be mapped in some implementations. In some implementations, multiple calyces may be mapped to provide increased spatial information/mapping see also [0114]-[0115] which disclose locating a kidney stone using an image-capturing device and identifying a target papilla that is exposed within a target Calyx through which access to the kidney stone may be achieved. Examiner thus notes that the information for identifying the substructure necessarily includes its position and orientation relative to the target. See also [0092] which discloses a target trajectory can be determined based on a variety of information including the anatomy of the patient (e.g. the location of organs with int eh patient relative to the target location).
Regarding claim 6,
Ayvali further discloses wherein the approach path is a linear, percutaneous approach path ([0175] which discloses the target trajectory 902 represents a straight line that passes through the papilla 914 and the point of the needle 17. See also at least fig. 13)
Regarding claim 7,
Ayvali further discloses wherein the entry into the substructure is a distal opening of the substructure (see at least fig. 13 and/or 14)
Regarding claim 8,
Ayvali further discloses further comprising generating a cylindrical model (at least fig. 17 (1700) and corresponding disclosure in at least [0198]) of the substructure based at least in part on the point cloud data ([0198] which discloses a three-dimensional surface map 1700 generated such as using a gaussian interpolation. Examiner notes that the three-dimensional surface map is considered to be include a cylindrical model of the substructure (i.e. the calyx and/or infundibula) [0058] discloses the funnel/tubular shaped anatomy associated with the calyces can be referred to as the infundibulum)
Regarding claim 9,
Ayvali further discloses wherein the approach path is along a centerline of the cylindrical model ([0175] which discloses the trajectory may be generally in-line with the axis of the infundibulum associated with the target calyx. See also at least fig. 10A 1006 depicting an approach path along a centerline of the target calyx and/or infundibulum, thus the approach path is along a centerline of the cylindrical model accordingly. And [0194] which discloses the percutaneous access path to the target anatomical site may be determined and/or aligned with the orientation of the target papilla/calyx, which may be generally in-line with the central axis of the associated infundibulum in some cases)
Regarding claim 17,
Ayvali further discloses wherein the approach path is based at least in part on a location of the target ([0176] which discloses The control system 50 can include control circuitry configured to determine a target trajectory 902 for inserting the needle 17 to assist the physician 5 in reaching the target location (e.g., the papilla 914). See also [0092] which discloses target/trajectory component 316 can also be configured to determine a target trajectory for a medical instrument or another object. A target trajectory can represent a desired path for accessing a target location and/or anatomical feature. A target trajectory can be determined based on a variety of information, such as a position of a medical instrument(s) (e.g., a needle, a scope, etc.), a target location within the human anatomy).
Regarding claim 18,
Ayvali further discloses wherein providing the graphical representation includes representing the approach path as a line from the target through a center of the distal opening of the substructure (see at least figs. 10A (1006) and 10B (1003) and corresponding disclosure in at least [0157]-[0158]) .
Regarding claim 19,
Ayvali further teaches wherein providing the graphical providing the graphic representation includes representing the approach path as a cylindrical range of vectors (at least figs. 10A (1002, 1004, and 1006)/10B (1001, 1003, and 1005) and corresponding disclosure in at least [0156]-[0158]) from the target through the distal opening of the substructure (See at least figs. 10A-10B)
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 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ayvali.
Regarding claim 10,
Wherein providing the graphical representation includes representing the approach path as a line along the centerline of the substructure (see at least fig. 10A/10B and 13).
It is not made explicitly clear if the graphical representation includes representing the approach path as a line along the centerline of the cylindrical model.
Nonetheless, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ayvali to include representing the approach path in the manner depicted in figs. 10A/10B and 13 around the centerline of the cylindrical model in order to allow a user to readily recognize the trajectories of the probe at various parked positions with respect to the calyx mapping. Such a modification would enhance a user’s ability to recognize the probe position and various trajectories associated therewith with respect the mapping of the Calyx.
Regarding claim 11,
Ayvali teaches the elements of claim 9 as previously stated. Ayvali furth teaches wherein providing the graphical representation includes representing the approach path as a cylindrical range of vectors around the centerline of the substructure (see at least fig. 10A/10B and corresponding disclosure in at least [0157] and [0158]).
It is not made explicitly clear if the graphical representation includes representing the approach path as a cylindrical range of vectors around the centerline of the cylindrical model.
Nonetheless, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ayvali to include representing the approach path in the manner depicted in figs. 10A/10B around the centerline of the cylindrical model in order to allow a user to readily recognize the trajectories of the probe at various parked positions with respect to the calyx mapping. Such a modification would enhance a user’s ability to recognize the probe position and various trajectories associated therewith with respect the mapping of the Calyx.
Claims 12-16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ayvali in view of Lachmanovich et al. (US 20160000520 A1), hereinafter Lachmanovich.
Regarding claim 12,
Ayvali teaches the elements of claim 9 as previously stated. Ayvali fails to explicitly teach wherein providing the graphical representation includes presenting the approach path as a cone of vectors converging at a point along the centerline of the cylindrical model.
Nonetheless, Lachmanovich, in a similar field of endeavor involving endoscopic procedures, teaches providing a graphical representation including presenting an approach path (at least fig. 4A (404) and corresponding disclosure in at least [0049]) as a cone of vectors converging at center point at a distal end of an extended working channel (196) of a bronchoscope (150) ([0050] which discloses In this instance by a cone shaped projection emanating from the center point of distal tip 193 of EWC 196 or locatable guide 192 and The cone length L indicates the maximum useful or effective distance a laparoscopic tool (e.g., a biopsy tool, a microwave or radiation ablation tool, a chemotherapy tool, a therapeutic medication application tool, a brachytherapy tool, a marker placement tool, or other similar laparoscopic tools) can extend beyond the distal end of EWC 196. The cone diameter D indicates the maximum probable distribution or deflection of a tool when extended beyond EWC 196).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ayvali to include a graphical representation as taught by Lachmanovich in order to allow user to readily recognize the maximum distance and probable deflection/distribution of the needle from the endoscope of Ayvali. Such a modification would allow a user to readily recognize whether the needle of Ayvali would be capable of effectively reaching/treating the target as the endoscope if driven toward the target position.
It would have been further obvious to a person having ordinary skill in the art before the effective filing date to have modified Ayvali, as currently modified to include presenting the approach path along the centerline of the cylindrical model in order to present the approach path with respect to the calyx mapping, thereby allowing the user to readily recognize that approach path with respect to the three-dimensional data mapping of the Calyx for appropriately positioning the tool.
Regarding claim 13,
Ayvali, as modified, further teaches wherein the point is at a proximal entry of the cylindrical model (Examiner notes that by positioning the approach path at the central axis of the tool, that the point is at a proximal entry of the cylindrical model (see for example fig. 13 in which the tool is positioned at a proximal entry of the infundibula/calyx), thus when presenting the approach path on the cylindrical model, it is noted that the point of convergence is at the proximal entry of the cylindrical model).
Regarding claim 14,
Ayvali, as modified, further teaches wherein the anatomic structure is the kidney (see at least fig. 10A/10B) and the point is near a renal pelvis of the kidney (see at least fig. 10A/10B in which the endoscope is positioned near the renal pelvis 71 (see [0058]), thus the point of convergence (i.e. the central axis of the working channel/endoscope) is near the renal pelvis of the kidney).
Regarding claim 15,
Ayvali, as modified, further teaches wherein a radius of the cone expands away from the tool (thus examiner notes that in the modified method the cone would expand toward a distal opening of the cylindrical model)
Regarding claim 16,
Ayvali, as modified, further teaches wherein the radius of the cone is limited by the deflection capabilities of the tool/needle (The cone diameter D indicates the maximum probable distribution or deflection of a tool when extended beyond EWC 196), however, fails to explicitly teach wherein the radius of the cone is limited by a radius of the distal opening of the cylindrical model.
Nonetheless, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the teachings of Ayvali, as currently modified, to further limit the radius of the cone by a radius of the distal opening of the cylindrical model in order to ensure that the needle would be capable of passing through the distal opening to the target accordingly.
Regarding claim 20,
Ayvali teaches the elements of claim 17 as previously stated. Ayvali fails to explicitly teach wherein providing the graphical representation includes representing the approach path as a range of vectors at different angles converging at the target.
Nonetheless, Lachmanovich, in a similar field of endeavor involving endoscopic procedures, teaches providing a graphical representation including presenting an approach path (at least fig. 4A (404) and corresponding disclosure in at least [0049]) as a range of vector at different angles converging at a center point at a distal end of an extended working channel (196) of a bronchoscope (150) ([0050] which discloses In this instance by a cone shaped projection emanating from the center point of distal tip 193 of EWC 196 or locatable guide 192 and The cone length L indicates the maximum useful or effective distance a laparoscopic tool (e.g., a biopsy tool, a microwave or radiation ablation tool, a chemotherapy tool, a therapeutic medication application tool, a brachytherapy tool, a marker placement tool, or other similar laparoscopic tools) can extend beyond the distal end of EWC 196. The cone diameter D indicates the maximum probable distribution or deflection of a tool when extended beyond EWC 196).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ayvali to include a graphical representation as taught by Lachmanovich in order to allow user to readily recognize the maximum distance and probable deflection/distribution of the needle from the endoscope of Ayvali. Such a modification would allow a user to readily recognize whether the needle of Ayvali would be capable of effectively reaching/treating the target as the endoscope if driven toward the target position.
Examiner notes that in the modified system the target may be interpreted as the final (or parking) position of the tool, thus the range of vectors at different angles in the modified system are considered to converge at the target.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 5712700552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797