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
This office action is in response to the communications filed on 09/02/2025, concerning Application No. 15/734,023. The response filed on 09/02/2025 is acknowledged. Presently, claims 16-30 remain pending.
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.
Claims 16-17 and 19-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Denissen (US Patent 9,430,717 B2, of record, cited in the applicant’s IDS filed on 12/01/2020, hereinafter Denissen).
Regarding claim 16, Denissen discloses (Figs. 1-4) a system (imaging system 1) for registering a device (shape sensing system 10) with a stored three-dimensional (3D) representation of a region of interest (see, e.g., Abstract, lines 1-3, “A system and method are provided for registering a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra-procedural imaging data”, and Col. 4, lines 15-22, “FIG. 1 is a block diagram of an imaging system 1 that registers a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra procedural imaging data by matching and aligning a stable shape from different sources. According to one embodiment of the present invention, the imaging system 1 includes a shape sensing system 10 that is used in the registration of a shape sensing coordinate system to another coordinate system”),
the device (10) comprising an outer body (surgical instrument 200, flexible sleeve 222) configured for maneuvering through a passage in the region of interest (see, e.g., Figs. 1-3, and Abstract, lines 1-3, “A system and method are provided for registering a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra-procedural imaging data”, and Col. 4, lines 26-57, “The shape sensing system 10 comprises a shape sensing fiber 212 disposed in or affixed to a surgical instrument 200. The instrument 200 may be any instrument used during an intervention, including but not limited to: a mechanical scalpel (lancet), a laser scalpel, an endoscope, microscopic imaging probes, a surgical stapler, a retractor, a cautery device (electrical or optical), a catheter, a chisel, a clamp, a probe, a trocar, scissors, or the like. The instrument 200 may be manipulated by a physician to perform an intervention procedure. […] The instrument 200 may be introduced endoluminally or endovascularly into a patient through an introducer 220, which may comprise one or more flexible and/or rigid sleeves, through which the instrument 200 may be advanced and/or retracted. According to one embodiment, shown in FIGS. 2 and 3, the instrument 200 is disposed in a flexible sleeve 222 which is disposed in a shorter rigid sleeve 224 used to introduce the instrument and flexible sleeve into a body lumen or vasculature. The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. The optical console 210 is operably connected to the shape sensing fiber 212. For example, the shape sensing fiber 212 may be connected to the optical console at an optical connector. The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain”),
the outer body (200, 222) comprising a tubular structure (surgical instrument 200) having an inner surface, an outer surface, an inner lumen defined by the inner surface and extending therethrough (see, e.g., Fig. 3, where the claimed tubular structure of the outer body corresponds to the disclosed surgical instrument 200, and where the disclosed surgical instrument 200 is indicated in the figure by the dotted inner circular tube structure, which is shown to have an inner surface (the surface of 200 adjacent to the white inner circle), an outer surface (the surface of 200 adjacent to the larger white circular tube), and an inner lumen (the white inner circle defined by the surface of 200 adjacent to the white inner circle)), and a force sensing region (plurality of optical scatterers of shape sensing fiber 212) integrated between the inner and outer surfaces (200) of the outer body (200, 222) (see, e.g., Col. 4, lines 26-57, “The shape sensing system 10 comprises a shape sensing fiber 212 disposed in or affixed to a surgical instrument 200. […] The instrument 200 may be introduced endoluminally or endovascularly into a patient through an introducer 220, which may comprise one or more flexible and/or rigid sleeves, through which the instrument 200 may be advanced and/or retracted. According to one embodiment, shown in FIGS. 2 and 3, the instrument 200 is disposed in a flexible sleeve 222 which is disposed in a shorter rigid sleeve 224 used to introduce the instrument and flexible sleeve into a body lumen or vasculature. The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. The optical console 210 is operably connected to the shape sensing fiber 212. For example, the shape sensing fiber 212 may be connected to the optical console at an optical connector. The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain”, where the shape sensing fiber 212 comprising the plurality of optical scatterers distributed thereon is disclosed to be affixed/integrated between the inner and outer surfaces of the surgical instrument 200, as depicted in Figure 3),
the force sensing region (plurality of optical scatterers of shape sensing fiber 212) configured for sensing an amount of axial forces exerted on a distal end of the outer body (200, 222), the force sensing region (plurality of optical scatterers of shape sensing fiber 212) having a force sensing distal end disposed proximal to the distal end of the outer body (200, 222) (see, e.g., Col. 4, lines 48-67 and Col. 5, lines 1-4, “The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. The optical console 210 is operably connected to the shape sensing fiber 212. For example, the shape sensing fiber 212 may be connected to the optical console at an optical connector. The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain. The optical console 210 interrogates the optical fiber, sending a broadband light signal along the optical fiber core and measuring the reflected wavelengths to determine length-resolved strain in the optical fiber core. Alternatively, the reflection spectrum may be obtained from a narrow band light source whereby the wavelength is swept in time. The strain data is then used to calculate the local curvature at each sensor, and the curvature data is compiled to calculate a three-dimensional shape of the shape sensing fiber 212, which corresponds to the shape of the instrument in which the shape sensing fiber is disposed or to which the shape sensing fiber is affixed. The optical console 210 may include a processor and may process the wavelength and strain data from the sensors”, where length-resolved strain (i.e., axial force applied in the lengthwise direction) in the optical fiber core is determined/measured by the plurality of optical scatterers that are distributed over the length of the optical fiber 212 in the core at the distal end of the instrument 200 in which the shape sensing fiber 212 is disposed or affixed to, such that the plurality of optical scatterers distributed over the length of the optical fiber 212 in the core at the distal end of the instrument 200 would be positioned proximal to the most distal end/tip of the instrument 200),
the device (10) being a shape sensing device (see, e.g., Abstract, lines 1-3, “A system and method are provided for registering a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra-procedural imaging data”, and Col. 4, lines 26-57, “The shape sensing system 10 comprises a shape sensing fiber 212 disposed in or affixed to a surgical instrument 200. […] The instrument 200 may be introduced endoluminally or endovascularly into a patient through an introducer 220, which may comprise one or more flexible and/or rigid sleeves, through which the instrument 200 may be advanced and/or retracted. According to one embodiment, shown in FIGS. 2 and 3, the instrument 200 is disposed in a flexible sleeve 222 which is disposed in a shorter rigid sleeve 224 used to introduce the instrument and flexible sleeve into a body lumen or vasculature. The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. The optical console 210 is operably connected to the shape sensing fiber 212. For example, the shape sensing fiber 212 may be connected to the optical console at an optical connector. The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain”) or a device having at least one of a electromagnetic (EM) sensor, insitu ultrasound sensor, or dielectric sensor (see, e.g., Col. 7, lines 53-55, “The storage device can be an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system (or apparatus or device)”),
the system (1) comprising a computing device (processor 110) and a non-transitory computer-readable storage medium (memory 130) storing instructions executable by the computing device (110) (see, e.g., Col. 3, lines 20-24, “According to another aspect of the present invention, a computer program product is provided for registering a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra procedural imaging data. The program product is encoded with: program instructions”, and Col. 7, lines 35-39, “Furthermore, the invention may take the form of a computer program product accessible from a computer-usable or computer-readable storage device providing program code for use by or in connection with a computer or any instruction execution system or device”; also see, e.g., Col. 5, lines 7-42) to:
detect, using the force sensing region (plurality of optical scatterers of shape sensing fiber 212) of the outer body (200, 222), the amount of axial forces exerted on the distal end of the outer body (200, 222) in the region of interest (see, e.g., Col. 4, lines 48-67 and Col. 5, lines 1-4, “The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. The optical console 210 is operably connected to the shape sensing fiber 212. For example, the shape sensing fiber 212 may be connected to the optical console at an optical connector. The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain. The optical console 210 interrogates the optical fiber, sending a broadband light signal along the optical fiber core and measuring the reflected wavelengths to determine length-resolved strain in the optical fiber core. Alternatively, the reflection spectrum may be obtained from a narrow band light source whereby the wavelength is swept in time. The strain data is then used to calculate the local curvature at each sensor, and the curvature data is compiled to calculate a three-dimensional shape of the shape sensing fiber 212, which corresponds to the shape of the instrument in which the shape sensing fiber is disposed or to which the shape sensing fiber is affixed. The optical console 210 may include a processor and may process the wavelength and strain data from the sensors”, where length-resolved strain (i.e., axial force applied in the lengthwise direction) in the optical fiber core is determined/measured by the plurality of optical scatterers that are distributed over the length of the optical fiber 212 in the core at the distal end of the instrument 200 in which the shape sensing fiber 212 is disposed or affixed to);
determine a plurality of points at which the distal end of the outer body (200, 222) contacts a surface of an object in the region of interest, based on the amount of axial forces exerted on the distal end when contacting the surface (see, e.g., Col. 4, lines 48-67 and Col. 5, lines 1-4, “The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. […] The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain. The optical console 210 interrogates the optical fiber, sending a broadband light signal along the optical fiber core and measuring the reflected wavelengths to determine length-resolved strain in the optical fiber core. […] The strain data is then used to calculate the local curvature at each sensor, and the curvature data is compiled to calculate a three-dimensional shape of the shape sensing fiber 212, which corresponds to the shape of the instrument in which the shape sensing fiber is disposed or to which the shape sensing fiber is affixed. The optical console 210 may include a processor and may process the wavelength and strain data from the sensors”, and Col. 6, lines 1-17, “According to one embodiment, the registration program 134 performs an initial alignment of the coordinate system of the shape sensing system 10 to a coordinate system from pre-procedural or intra-procedural imaging data (Step 410). The initial registration may be performed using any of a variety of known methods. For example, the initial registration may be performed by touching the shape sensing enabled instrument to a fiducial or an anatomical landmark corresponding to identifiable points in the imaging data. The registration program 134 determines a stable curvature (step 420). To determine a stable curvature, the registration program first identifies a curve in the shape sensing fiber 212. The shape sensing fiber 212 provides a polyline curve 500, as shown in FIG. 5. The polyline curve is a curve formed by multiple points (corresponding to the sensor locations) with each point subsequent on the shape sensing fiber 212 to the previous point”); and
register the determined plurality of points with points in the stored 3D representation of the region of interest so that the registered points are in a common space (see, e.g., Col. 6, lines 53-62 and Col. 7, lines 9-29, “Returning to FIG. 4, once a stable curvature is determined (Step 420), curvatures are matched to the stable curvature from another source (Step 430). The other source may be another shape reconstruction from a different time. Alternatively, the other source may be data from pre-procedural or intra-procedural imaging, such as an anatomical volume reconstruction from computer tomography. In another embodiment the other source may be a different shape sensing fiber subject to the same shape constraint as the first shape sensing fiber. […] The registration program 134 aligns the matching curvatures (Step 440). A translation and rotation are calculated to bring the three-dimensional curvature from the different source with matching bend radius into alignment with the three-dimensional curvature from the stored stable curvature. The translation and rotation needed for alignment may be expressed in the form of a transformation matrix, which may be applied to the shape reconstruction to align it to the imaging data. The matrix may be calculated from coordinates of points on the matching curvatures. According to one embodiment, the registration program 134 aligns the curvatures by taking the three points (bend point, proximal point, and distal point) from each curvature to form triangles which lie in the planes of the respective bends, then aligning the triangles. According to one embodiment, the registration program 134 displays the shape reconstruction for the newly registered curvature on a pre-procedural or an intra-procedural image construction consistent with the registration (Step 450)”).
Regarding claim 17, Denissen discloses the system of claim 16. Denissen further discloses (Figs. 1-4) wherein said non-transitory computer-readable storage medium (memory 130) stores the instructions executable by the computing device (processor 110) to implement said registration of the determined plurality of points by at least: determining sets of 3D coordinates of the determined plurality of points in a shape space; and registering the sets of 3D coordinates to the points in the stored 3D representation, the instructions using a registration algorithm (see, e.g., Col. 6, lines 53-62 and Col. 7, lines 9-29, “Returning to FIG. 4, once a stable curvature is determined (Step 420), curvatures are matched to the stable curvature from another source (Step 430). The other source may be another shape reconstruction from a different time. Alternatively, the other source may be data from pre-procedural or intra-procedural imaging, such as an anatomical volume reconstruction from computer tomography. In another embodiment the other source may be a different shape sensing fiber subject to the same shape constraint as the first shape sensing fiber. […] The registration program 134 aligns the matching curvatures (Step 440). A translation and rotation are calculated to bring the three-dimensional curvature from the different source with matching bend radius into alignment with the three-dimensional curvature from the stored stable curvature. The translation and rotation needed for alignment may be expressed in the form of a transformation matrix, which may be applied to the shape reconstruction to align it to the imaging data. The matrix may be calculated from coordinates of points on the matching curvatures. According to one embodiment, the registration program 134 aligns the curvatures by taking the three points (bend point, proximal point, and distal point) from each curvature to form triangles which lie in the planes of the respective bends, then aligning the triangles. According to one embodiment, the registration program 134 displays the shape reconstruction for the newly registered curvature on a pre-procedural or an intra-procedural image construction consistent with the registration (Step 450)”).
Regarding claim 19, Denissen discloses the system of claim 16. Denissen further discloses (Figs. 1-4) wherein the stored 3D representation of the region of interest comprises an x-ray image, an MR image, a CT image, a cone beam CT (CBCT) image, a positron emission tomography (PET) scan image, an ultrasound image or an optical image (see, e.g., Col. 5, lines 34-43, “The processing system 100 further comprises a registration program 134 stored on the memory 130 and executed by the processor 110 to register a coordinate system for the shape sensing system 10 to a coordinate system for pre-procedural or intra procedural imaging data. The imaging data may be stored imaging data or real-time imaging data from an MRI, X-ray, ultrasound, or any other type of imaging system appropriate for acquiring images of anatomic structures. According to one embodiment, the imaging system data comprises a three-dimensional image volume”).
Regarding claim 20, Denissen discloses the system of claim 16. Denissen further discloses (Figs. 1-4) wherein the stored 3D representation of the region of interest comprises a segmented surface model (see, e.g., Col. 1, lines 34-43, “In one application for shape sensing technology, a shape sensing optical fiber may be integrated into a tether attached to a surgical instrument and/or the instrument itself and used for instrument tracking. The fiber-optically tracked device is introduced endovascularly or endoluminally. To use the optical fiber for instrument tracking, an initial registration of the optical fiber coordinate system to a reference coordinate system is required. The reference coordinate system may be, for example, a 3D anatomical model derived from segmenting a Cone Beam Computer Tomography (CBCT) scan”).
Regarding claim 21, Denissen discloses the system of claim 16. Denissen further discloses (Figs. 1-4) wherein the stored 3D representation of the region of interest comprises a known signature that is enabled to affect shape data of the passage in the region of interest (see, e.g., Abstract, “A system and method are provided for registering a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra-procedural imaging data. A stable curvature in a shape reconstruction is identified and matched to another curvature, where the other curvature is from another shape construction from a subsequent time or from imaging data from another imaging modality. The matched curvatures are aligned, aligning the coordinate systems for the respective curvatures”, and Col. 2, lines 19-31, “According to one aspect of the present invention, a system is provided for registering a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra procedural imaging data. The system comprises one or more surgical instruments incorporating an optical fiber with shape sensing sensors. An optical console is operably connected with the optical fiber and interrogates the optical shape sensors and determines the three-dimensional shape of the instrument from the return signals. A processor registers the coordinate system of the shape sensing fiber to a coordinate system of imaging data by matching a stable curvature in the optical fiber with a curvature from a different source and aligns the matched curvatures”, where the known signature is the curvature identified, matched, and aligned to another curvature).
Regarding claim 22, Denissen discloses the system of claim 21. Denissen further discloses (Figs. 1-4) wherein the known signature comprises at least one of a thermal signature or a defined curvature signature (see, e.g., Abstract, “A system and method are provided for registering a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra-procedural imaging data. A stable curvature in a shape reconstruction is identified and matched to another curvature, where the other curvature is from another shape construction from a subsequent time or from imaging data from another imaging modality. The matched curvatures are aligned, aligning the coordinate systems for the respective curvatures”, and Col. 2, lines 19-31, “According to one aspect of the present invention, a system is provided for registering a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra procedural imaging data. The system comprises one or more surgical instruments incorporating an optical fiber with shape sensing sensors. An optical console is operably connected with the optical fiber and interrogates the optical shape sensors and determines the three-dimensional shape of the instrument from the return signals. A processor registers the coordinate system of the shape sensing fiber to a coordinate system of imaging data by matching a stable curvature in the optical fiber with a curvature from a different source and aligns the matched curvatures”, where the known signature is the curvature identified, matched, and aligned to another curvature).
Regarding claim 23, Denissen discloses the system of claim 21. Denissen further discloses (Figs. 1-4) wherein the known signature comprises a profile of navigation signatures derived from at least one previous procedure involving shape sensing navigation of the passage in the region of interest (see, e.g., Col. 6, lines 53-59, “Returning to FIG. 4, once a stable curvature is determined (Step 420), curvatures are matched to the stable curvature from another source (Step 430). The other source may be another shape reconstruction from a different time. Alternatively, the other source may be data from pre-procedural or intra-procedural imaging, such as an anatomical volume reconstruction from computer tomography”, where the known curvature is derived from another shape reconstruction from a different time (i.e., a previous procedure)).
Regarding claim 24, Denissen discloses the system of claim 16. Denissen further discloses (Figs. 1-4) wherein said non-transitory computer-readable storage medium (memory 130) storing the instructions is executable by the computing device (processor 110) to further: determine stiffness of the passage at the plurality of points at which the distal end of the outer body (surgical instrument 200, flexible sleeve 222) contacts an inner surface of the passage, based on the amount of axial forces exerted on the distal end, as detected using the force sensing region (plurality of optical scatterers of shape sensing fiber 212), wherein said stored executable instructions are further adapted to implement said registration of the determined plurality of points with the points in the stored 3D representation of the region of interest to include incorporating indications of the stiffness for each of the registered points in the common space (see, e.g., Col. 4, lines 48-67 and Col. 5, lines 1-4, “The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. The optical console 210 is operably connected to the shape sensing fiber 212. For example, the shape sensing fiber 212 may be connected to the optical console at an optical connector. The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain. The optical console 210 interrogates the optical fiber, sending a broadband light signal along the optical fiber core and measuring the reflected wavelengths to determine length-resolved strain in the optical fiber core. Alternatively, the reflection spectrum may be obtained from a narrow band light source whereby the wavelength is swept in time. The strain data is then used to calculate the local curvature at each sensor, and the curvature data is compiled to calculate a three-dimensional shape of the shape sensing fiber 212, which corresponds to the shape of the instrument in which the shape sensing fiber is disposed or to which the shape sensing fiber is affixed. The optical console 210 may include a processor and may process the wavelength and strain data from the sensors”, where stiffness information is known in the art to be determined by strain information).
Regarding claim 25, Denissen discloses the system of claim 16. Denissen further discloses (Figs. 1-4) wherein said non-transitory computer-readable storage medium (memory 130) storing the instructions is executable by the computing device (processor 110) to further: indicate a position of the device (shape sensing system 10) when navigating through the passage using the registered points (see, e.g., Col. 4, lines 48-67 and Col. 5, lines 1-4, “The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. The optical console 210 is operably connected to the shape sensing fiber 212. For example, the shape sensing fiber 212 may be connected to the optical console at an optical connector. The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain. The optical console 210 interrogates the optical fiber, sending a broadband light signal along the optical fiber core and measuring the reflected wavelengths to determine length-resolved strain in the optical fiber core. Alternatively, the reflection spectrum may be obtained from a narrow band light source whereby the wavelength is swept in time. The strain data is then used to calculate the local curvature at each sensor, and the curvature data is compiled to calculate a three-dimensional shape of the shape sensing fiber 212, which corresponds to the shape of the instrument in which the shape sensing fiber is disposed or to which the shape sensing fiber is affixed. The optical console 210 may include a processor and may process the wavelength and strain data from the sensors”, where the plurality of optical scatterers in which the strain is measured from are positioned at certain lengths of the optical fiber 212, and therefore would indicate the position of the fiber and the three-dimensional shape of the shape sensing fiber 212, which corresponds to the shape of the instrument 200/device 10 in which the shape sensing fiber 212 is disposed or affixed to).
Regarding claim 26, Denissen discloses the system of claim 16. Denissen further discloses (Figs. 1-4) wherein said non-transitory computer-readable storage medium (memory 130) storing the instructions is executable by the computing device (processor 110) to further:
define a planned path in the stored 3D representation of the region of interest, the planned path substantially corresponding to the passage (see, e.g., Col. 4, lines 26-47, “The shape sensing system 10 comprises a shape sensing fiber 212 disposed in or affixed to a surgical instrument 200. The instrument 200 may be any instrument used during an intervention, including but not limited to: a mechanical scalpel (lancet), a laser scalpel, an endoscope, microscopic imaging probes, a surgical stapler, a retractor, a cautery device (electrical or optical), a catheter, a chisel, a clamp, a probe, a trocar, scissors, or the like. The instrument 200 may be manipulated by a physician to perform an intervention procedure. […] The instrument 200 may be introduced endoluminally or endovascularly into a patient through an introducer 220, which may comprise one or more flexible and/or rigid sleeves, through which the instrument 200 may be advanced and/or retracted. According to one embodiment, shown in FIGS. 2 and 3, the instrument 200 is disposed in a flexible sleeve 222 which is disposed in a shorter rigid sleeve 224 used to introduce the instrument and flexible sleeve into a body lumen or vasculature”, and Col. 5, lines 34-43, “The processing system 100 further comprises a registration program 134 stored on the memory 130 and executed by the processor 110 to register a coordinate system for the shape sensing system 10 to a coordinate system for pre-procedural or intra procedural imaging data. The imaging data may be stored imaging data or real-time imaging data from an MRI, X-ray, ultrasound, or any other type of imaging system appropriate for acquiring images of anatomic structures. According to one embodiment, the imaging system data comprises a three-dimensional image volume”);
at an initial time, register an initial position of the device (shape sensing system 10) and the planned path in a 3D shape space, and determine an initial transformation using the registration in the 3D shape space to transform the initial position of the device (10) to a 3D region space of the stored 3D representation of the region of interest (see, e.g., Col. 6, lines 1-9, “the registration program 134 performs an initial alignment of the coordinate system of the shape sensing system 10 to a coordinate system from pre-procedural or intra-procedural imaging data (Step 410). The initial registration may be performed using any of a variety of known methods. For example, the initial registration may be performed by touching the shape sensing enabled instrument to a fiducial or an anatomical landmark corresponding to identifiable points in the imaging data”);
at subsequent times, while continuing to navigate the device (10) through the passage, apply the initial transformation to the device (10) to iteratively transform subsequent positions of the device (10), determined using at least one EM sensor, corresponding to the subsequent times from the 3D shape space into the 3D region space (see, e.g., Col. 6, lines 10-17, “The registration program 134 determines a stable curvature (step 420). To determine a stable curvature, the registration program first identifies a curve in the shape sensing fiber 212. The shape sensing fiber 212 provides a polyline curve 500, as shown in FIG. 5. The polyline curve is a curve formed by multiple points (corresponding to the sensor locations) with each point subsequent on the shape sensing fiber 212 to the previous point”, and Col. 7, lines 53-55, “The storage device can be an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system (or apparatus or device)”);
determine a best overlapping region between the planned path and the subsequent positions of the device (10) in the 3D region space, the best overlapping region comprising a portion of the stored 3D representation of the region of interest in which the subsequent positions of the device (10) most closely coincide with the planned path (see, e.g., Col. 6, lines 35-52, “The registration program 134 compares curvatures temporally (i.e., over subsequent shape reconstructions) to check that a bend is stable (Step 422). For clinical purposes, a bend as distally located along the shape as possible is preferred, because the displacement of tip of the instrument with respect to the bend will be minimized. If the distance from the origin of the shape to a stable physical constraint on the instrument (and shape sensing fiber) is known, for example by using a curved introducer, the search window for bend radii can be limited to positions at the geodesic distance for the known stable physical constraint. The registration program determines whether or not the curvature or bend is stable (Step 425). If the bend radii from subsequent shape reconstructions match within a predetermined margin of error the curvature is determined to be stable (Y branch from step 4125). If the curvature is not stable (N branch from step 425) additional bends are tested (Step 421)”, where the best overlapping region includes the region in which the curvature is determined to be stable);
register the subsequent positions of the device (10) only in the best overlapping region and the planned path only in the best overlapping region in the 3D space shape, and determining an updated transformation algorithm using the subsequent registration in the best overlapping region (see, e.g., Col. 6, lines 53-67 and Col. 7, lines 1-19, “Returning to FIG. 4, once a stable curvature is determined (Step 420), curvatures are matched to the stable curvature from another source (Step 430). The other source may be another shape reconstruction from a different time. Alternatively, the other source may be data from pre-procedural or intra-procedural imaging, such as an anatomical volume reconstruction from computer tomography. In another embodiment the other source may be a different shape sensing fiber subject to the same shape constraint as the first shape sensing fiber. The curvatures are matched by comparing the bend radii from the different curvatures of different curves as shown in FIG. 6. The bend radius of the curve 500 (stored from step 420) defined by points 501, 502, 503 is matched to the bend radius of curve 600 (from a different source) defined by points 610, 602, 603. If the bend radii match within a predetermined margin of error, then the curvatures are determined to match. Because the points lie at discrete distances, the curve of the new shape may have shifted between positions of the reference shape. […] The registration program 134 aligns the matching curvatures (Step 440). A translation and rotation are calculated to bring the three-dimensional curvature from the different source with matching bend radius into alignment with the three-dimensional curvature from the stored stable curvature. The translation and rotation needed for alignment may be expressed in the form of a transformation matrix, which may be applied to the shape reconstruction to align it to the imaging data. The matrix may be calculated from coordinates of points on the matching curvatures”, where the updated transformation corresponds to the disclosed transformation matrix); and
apply the updated transformation algorithm to the device (10) to again transform the subsequent positions of the device (10), determined using the at least one EM sensor, from the 3D shape space into the 3D region space (see, e.g., Col. 7, lines 15-19, “The translation and rotation needed for alignment may be expressed in the form of a transformation matrix, which may be applied to the shape reconstruction to align it to the imaging data. The matrix may be calculated from coordinates of points on the matching curvatures”, where the updated transformation corresponds to the disclosed transformation matrix that is applied to the reconstruction, and Col. 7, lines 53-55, “The storage device can be an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system (or apparatus or device)”).
Regarding claim 27, Denissen discloses (Figs. 1-4) a method for registering a shape sensing device (shape sensing system 10) with a three-dimensional (3D) representation of a region of interest (see, e.g., Abstract, lines 1-3, “A system and method are provided for registering a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra-procedural imaging data”, and Col. 4, lines 15-22, “FIG. 1 is a block diagram of an imaging system 1 that registers a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra procedural imaging data by matching and aligning a stable shape from different sources. According to one embodiment of the present invention, the imaging system 1 includes a shape sensing system 10 that is used in the registration of a shape sensing coordinate system to another coordinate system”),
the shape sensing device (10) comprising an outer body (surgical instrument 200, flexible sleeve 222) configured for maneuvering through a passage in the region of interest (see, e.g., Figs. 1-3, and Abstract, lines 1-3, “A system and method are provided for registering a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra-procedural imaging data”, and Col. 4, lines 26-57, “The shape sensing system 10 comprises a shape sensing fiber 212 disposed in or affixed to a surgical instrument 200. The instrument 200 may be any instrument used during an intervention, including but not limited to: a mechanical scalpel (lancet), a laser scalpel, an endoscope, microscopic imaging probes, a surgical stapler, a retractor, a cautery device (electrical or optical), a catheter, a chisel, a clamp, a probe, a trocar, scissors, or the like. The instrument 200 may be manipulated by a physician to perform an intervention procedure. […] The instrument 200 may be introduced endoluminally or endovascularly into a patient through an introducer 220, which may comprise one or more flexible and/or rigid sleeves, through which the instrument 200 may be advanced and/or retracted. According to one embodiment, shown in FIGS. 2 and 3, the instrument 200 is disposed in a flexible sleeve 222 which is disposed in a shorter rigid sleeve 224 used to introduce the instrument and flexible sleeve into a body lumen or vasculature. The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. The optical console 210 is operably connected to the shape sensing fiber 212. For example, the shape sensing fiber 212 may be connected to the optical console at an optical connector. The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain”),
the outer body (200, 222) comprising a tubular wall (surgical instrument 200), an inner lumen, defined thereby (see, e.g., Fig. 3, where the claimed tubular structure of the outer body corresponds to the disclosed surgical instrument 200, and where the disclosed surgical instrument 200 is indicated in the figure by the dotted inner circular tube structure, which is shown to have an inner surface (the surface of 200 adjacent to the white inner circle), an outer surface (the surface of 200 adjacent to the larger white circular tube), and an inner lumen (the white inner circle defined by the inner surface of 200 adjacent to the white inner circle)), and including a force sensing region (plurality of optical scatterers of shape sensing fiber 212) integrated within the tubular wall (200) (see, e.g., Col. 4, lines 26-57, “The shape sensing system 10 comprises a shape sensing fiber 212 disposed in or affixed to a surgical instrument 200. […] The instrument 200 may be introduced endoluminally or endovascularly into a patient through an introducer 220, which may comprise one or more flexible and/or rigid sleeves, through which the instrument 200 may be advanced and/or retracted. According to one embodiment, shown in FIGS. 2 and 3, the instrument 200 is disposed in a flexible sleeve 222 which is disposed in a shorter rigid sleeve 224 used to introduce the instrument and flexible sleeve into a body lumen or vasculature. The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. The optical console 210 is operably connected to the shape sensing fiber 212. For example, the shape sensing fiber 212 may be connected to the optical console at an optical connector. The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain”, where the shape sensing fiber 212 comprising the plurality of optical scatterers distributed thereon is disclosed to be affixed/integrated between the inner and outer surfaces of the surgical instrument 200, as depicted in Figure 3),
the force sensing region (plurality of optical scatterers of shape sensing fiber 212) configured for sensing an amount of axial forces exerted on a distal end of the outer body (200, 222), the force sensing region (plurality of optical scatterers of shape sensing fiber 212) having a force sensing distal end disposed proximal to the distal end of the outer body (200, 222) (see, e.g., Col. 4, lines 48-67 and Col. 5, lines 1-4, “The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. The optical console 210 is operably connected to the shape sensing fiber 212. For example, the shape sensing fiber 212 may be connected to the optical console at an optical connector. The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain. The optical console 210 interrogates the optical fiber, sending a broadband light signal along the optical fiber core and measuring the reflected wavelengths to determine length-resolved strain in the optical fiber core. Alternatively, the reflection spectrum may be obtained from a narrow band light source whereby the wavelength is swept in time. The strain data is then used to calculate the local curvature at each sensor, and the curvature data is compiled to calculate a three-dimensional shape of the shape sensing fiber 212, which corresponds to the shape of the instrument in which the shape sensing fiber is disposed or to which the shape sensing fiber is affixed. The optical console 210 may include a processor and may process the wavelength and strain data from the sensors”, where length-resolved strain (i.e., axial force applied in the lengthwise direction) in the optical fiber core is determined/measured by the plurality of optical scatterers that are distributed over the length of the optical fiber 212 in the core at the distal end of the instrument 200 in which the shape sensing fiber 212 is disposed or affixed to, such that the plurality of optical scatterers distributed over the length of the optical fiber 212 in the core at the distal end of the instrument 200 would be positioned proximal to the most distal end/tip of the instrument 200),
the method comprising:
detecting, using the force sensing region (plurality of optical scatterers of shape sensing fiber 212) of the outer body (200, 222), the amount of axial forces exerted on the distal end of the outer body (200, 222) in the region of interest (see, e.g., Col. 4, lines 48-67 and Col. 5, lines 1-4, “The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. The optical console 210 is operably connected to the shape sensing fiber 212. For example, the shape sensing fiber 212 may be connected to the optical console at an optical connector. The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain. The optical console 210 interrogates the optical fiber, sending a broadband light signal along the optical fiber core and measuring the reflected wavelengths to determine length-resolved strain in the optical fiber core. Alternatively, the reflection spectrum may be obtained from a narrow band light source whereby the wavelength is swept in time. The strain data is then used to calculate the local curvature at each sensor, and the curvature data is compiled to calculate a three-dimensional shape of the shape sensing fiber 212, which corresponds to the shape of the instrument in which the shape sensing fiber is disposed or to which the shape sensing fiber is affixed. The optical console 210 may include a processor and may process the wavelength and strain data from the sensors”, where length-resolved strain (i.e., axial force applied in the lengthwise direction) in the optical fiber core is determined/measured by the plurality of optical scatterers that are distributed over the length of the optical fiber 212 in the core at the distal end of the instrument 200 in which the shape sensing fiber 212 is disposed or affixed to);
determining a plurality of points at which the distal end of the outer body (200, 222) contacts a surface of an object in the region of interest, based on the amount of axial forces exerted on the distal end when contacting the surface as detected using the force sensing region (plurality of optical scatterers of shape sensing fiber 212) (see, e.g., Col. 4, lines 48-67 and Col. 5, lines 1-4, “The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. […] The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain. The optical console 210 interrogates the optical fiber, sending a broadband light signal along the optical fiber core and measuring the reflected wavelengths to determine length-resolved strain in the optical fiber core. […] The strain data is then used to calculate the local curvature at each sensor, and the curvature data is compiled to calculate a three-dimensional shape of the shape sensing fiber 212, which corresponds to the shape of the instrument in which the shape sensing fiber is disposed or to which the shape sensing fiber is affixed. The optical console 210 may include a processor and may process the wavelength and strain data from the sensors”, and Col. 6, lines 1-17, “According to one embodiment, the registration program 134 performs an initial alignment of the coordinate system of the shape sensing system 10 to a coordinate system from pre-procedural or intra-procedural imaging data (Step 410). The initial registration may be performed using any of a variety of known methods. For example, the initial registration may be performed by touching the shape sensing enabled instrument to a fiducial or an anatomical landmark corresponding to identifiable points in the imaging data. The registration program 134 determines a stable curvature (step 420). To determine a stable curvature, the registration program first identifies a curve in the shape sensing fiber 212. The shape sensing fiber 212 provides a polyline curve 500, as shown in FIG. 5. The polyline curve is a curve formed by multiple points (corresponding to the sensor locations) with each point subsequent on the shape sensing fiber 212 to the previous point”); and
registering the determined plurality of points with points in the 3D representation of the region of interest so that the registered points are in a common space (see, e.g., Col. 6, lines 53-62 and Col. 7, lines 9-29, “Returning to FIG. 4, once a stable curvature is determined (Step 420), curvatures are matched to the stable curvature from another source (Step 430). The other source may be another shape reconstruction from a different time. Alternatively, the other source may be data from pre-procedural or intra-procedural imaging, such as an anatomical volume reconstruction from computer tomography. In another embodiment the other source may be a different shape sensing fiber subject to the same shape constraint as the first shape sensing fiber. […] The registration program 134 aligns the matching curvatures (Step 440). A translation and rotation are calculated to bring the three-dimensional curvature from the different source with matching bend radius into alignment with the three-dimensional curvature from the stored stable curvature. The translation and rotation needed for alignment may be expressed in the form of a transformation matrix, which may be applied to the shape reconstruction to align it to the imaging data. The matrix may be calculated from coordinates of points on the matching curvatures. According to one embodiment, the registration program 134 aligns the curvatures by taking the three points (bend point, proximal point, and distal point) from each curvature to form triangles which lie in the planes of the respective bends, then aligning the triangles. According to one embodiment, the registration program 134 displays the shape reconstruction for the newly registered curvature on a pre-procedural or an intra-procedural image construction consistent with the registration (Step 450)”).
Regarding claim 28, Denissen discloses the method of claim 27. Denissen further discloses (Figs. 1-4) wherein the shape sensing device (shape sensing system 10) includes an optical shape sensing (OSS) device disposed within the inner lumen of the outer body (surgical instrument 200, flexible sleeve 222) (see, e.g., Abstract, lines 1-3, “A system and method are provided for registering a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra-procedural imaging data”, and Col. 4, lines 26-57, “The shape sensing system 10 comprises a shape sensing fiber 212 disposed in or affixed to a surgical instrument 200. […] The instrument 200 may be introduced endoluminally or endovascularly into a patient through an introducer 220, which may comprise one or more flexible and/or rigid sleeves, through which the instrument 200 may be advanced and/or retracted. According to one embodiment, shown in FIGS. 2 and 3, the instrument 200 is disposed in a flexible sleeve 222 which is disposed in a shorter rigid sleeve 224 used to introduce the instrument and flexible sleeve into a body lumen or vasculature. The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. The optical console 210 is operably connected to the shape sensing fiber 212. For example, the shape sensing fiber 212 may be connected to the optical console at an optical connector. The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain”), and wherein the determining the plurality of points comprises determining a plurality of positions of the distal end of the outer body (200, 222) using optical shape sensing when the distal end contacts an inner surface of the passage, the determined plurality of positions corresponding to the plurality of points (see, e.g., Col. 2, lines 19-31, “According to one aspect of the present invention, a system is provided for registering a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra procedural imaging data. The system comprises one or more surgical instruments incorporating an optical fiber with shape sensing sensors. An optical console is operably connected with the optical fiber and interrogates the optical shape sensors and determines the three-dimensional shape of the instrument from the return signals. A processor registers the coordinate system of the shape sensing fiber to a coordinate system of imaging data by matching a stable curvature in the optical fiber with a curvature from a different source and aligns the matched curvatures”, and Col. 6, lines 1-17, “According to one embodiment, the registration program 134 performs an initial alignment of the coordinate system of the shape sensing system 10 to a coordinate system from pre-procedural or intra-procedural imaging data (Step 410). The initial registration may be performed using any of a variety of known methods. For example, the initial registration may be performed by touching the shape sensing enabled instrument to a fiducial or an anatomical landmark corresponding to identifiable points in the imaging data. The registration program 134 determines a stable curvature (step 420). To determine a stable curvature, the registration program first identifies a curve in the shape sensing fiber 212. The shape sensing fiber 212 provides a polyline curve 500, as shown in FIG. 5. The polyline curve is a curve formed by multiple points (corresponding to the sensor locations) with each point subsequent on the shape sensing fiber 212 to the previous point”).
Regarding claim 29, Denissen discloses the method of claim 27. Denissen further discloses (Figs. 1-4) wherein the shape sensing device (shape sensing system 10) comprises a guidewire or a catheter (see, e.g., Col. 2, lines 44-48, “According to one embodiment, the different source is a shape reconstruction from a different shape sensing fiber. For example, multi-tether tracking can be used for a shape sensed catheter and for a shape-sensed guidewire inside the catheter”, and Col. 4, lines 26-33, “The shape sensing system 10 comprises a shape sensing fiber 212 disposed in or affixed to a surgical instrument 200. The instrument 200 may be any instrument used during an intervention, including but not limited to: a mechanical scalpel (lancet), a laser scalpel, an endoscope, microscopic imaging probes, a surgical stapler, a retractor, a cautery device (electrical or optical), a catheter, a chisel, a clamp, a probe, a trocar, scissors, or the like”).
Regarding claim 30, Denissen discloses (Figs. 1-4) a method for registering a device (shape sensing system 10) with a previously obtained three-dimensional (3D) representation of a region of interest (see, e.g., Abstract, lines 1-3, “A system and method are provided for registering a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra-procedural imaging data”, and Col. 4, lines 15-22, “FIG. 1 is a block diagram of an imaging system 1 that registers a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra procedural imaging data by matching and aligning a stable shape from different sources. According to one embodiment of the present invention, the imaging system 1 includes a shape sensing system 10 that is used in the registration of a shape sensing coordinate system to another coordinate system”),
the device (10) comprising an elongated outer body (surgical instrument 200, flexible sleeve 222) configured for maneuvering through a passage in the region of interest, the device (10) including a shape sensing device including an optical fiber (shape sensing fiber 212) extending through an inner lumen of the elongated outer body (200, 222) (see, e.g., Abstract, lines 1-3, “A system and method are provided for registering a coordinate system for a shape sensing system to a coordinate system for pre-procedural or intra-procedural imaging data”, and Col. 4, lines 26-57, “The shape sensing system 10 comprises a shape sensing fiber 212 disposed in or affixed to a surgical instrument 200. The instrument 200 may be any instrument used during an intervention, including but not limited to: a mechanical scalpel (lancet), a laser scalpel, an endoscope, microscopic imaging probes, a surgical stapler, a retractor, a cautery device (electrical or optical), a catheter, a chisel, a clamp, a probe, a trocar, scissors, or the like. The instrument 200 may be manipulated by a physician to perform an intervention procedure. […] The instrument 200 may be introduced endoluminally or endovascularly into a patient through an introducer 220, which may comprise one or more flexible and/or rigid sleeves, through which the instrument 200 may be advanced and/or retracted. According to one embodiment, shown in FIGS. 2 and 3, the instrument 200 is disposed in a flexible sleeve 222 which is disposed in a shorter rigid sleeve 224 used to introduce the instrument and flexible sleeve into a body lumen or vasculature. The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. The optical console 210 is operably connected to the shape sensing fiber 212. For example, the shape sensing fiber 212 may be connected to the optical console at an optical connector. The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain”) or an interventional device having at least one electromagnetic (EM) sensor attached to a distal end of the elongated outer body (200, 222) (see, e.g., Col. 7, lines 53-55, “The storage device can be an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system (or apparatus or device)”),
the elongated outer body (200, 222) including a force sensing region (plurality of optical scatterers of shape sensing fiber 212) disposed outside the inner lumen and within the elongated outer body (200, 222) and configured for sensing an amount of axial forces exerted on the distal end of the elongated outer body (200, 222), the force sensing region (plurality of optical scatterers of shape sensing fiber 212) having a force sensing distal end disposed proximal to the distal end of the elongated outer body (200, 222) (see, e.g., Col. 4, lines 26-67 and Col. 5, lines 1-4, “The shape sensing system 10 comprises a shape sensing fiber 212 disposed in or affixed to a surgical instrument 200. […] The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. The optical console 210 is operably connected to the shape sensing fiber 212. For example, the shape sensing fiber 212 may be connected to the optical console at an optical connector. The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain. The optical console 210 interrogates the optical fiber, sending a broadband light signal along the optical fiber core and measuring the reflected wavelengths to determine length-resolved strain in the optical fiber core. Alternatively, the reflection spectrum may be obtained from a narrow band light source whereby the wavelength is swept in time. The strain data is then used to calculate the local curvature at each sensor, and the curvature data is compiled to calculate a three-dimensional shape of the shape sensing fiber 212, which corresponds to the shape of the instrument in which the shape sensing fiber is disposed or to which the shape sensing fiber is affixed. The optical console 210 may include a processor and may process the wavelength and strain data from the sensors”, where the shape sensing fiber 212 comprising the plurality of optical scatterers distributed thereon is disclosed to be affixed/integrated between the inner and outer surfaces of the surgical instrument 200, as depicted in Figure 3, and where length-resolved strain (i.e., axial force applied in the lengthwise direction) in the optical fiber core is determined/measured by the plurality of optical scatterers that are distributed over the length of the optical fiber 212 in the core at the distal end of the instrument 200 in which the shape sensing fiber 212 is disposed or affixed to, such that the plurality of optical scatterers distributed over the length of the optical fiber 212 in the core at the distal end of the instrument 200 would be positioned proximal to the most distal end/tip of the instrument 200),
the method comprising:
defining a planned path in the previously obtained 3D representation of the region of interest, the planned path substantially corresponding to the passage (see, e.g., Col. 4, lines 26-47, “The shape sensing system 10 comprises a shape sensing fiber 212 disposed in or affixed to a surgical instrument 200. The instrument 200 may be any instrument used during an intervention, including but not limited to: a mechanical scalpel (lancet), a laser scalpel, an endoscope, microscopic imaging probes, a surgical stapler, a retractor, a cautery device (electrical or optical), a catheter, a chisel, a clamp, a probe, a trocar, scissors, or the like. The instrument 200 may be manipulated by a physician to perform an intervention procedure. […] The instrument 200 may be introduced endoluminally or endovascularly into a patient through an introducer 220, which may comprise one or more flexible and/or rigid sleeves, through which the instrument 200 may be advanced and/or retracted. According to one embodiment, shown in FIGS. 2 and 3, the instrument 200 is disposed in a flexible sleeve 222 which is disposed in a shorter rigid sleeve 224 used to introduce the instrument and flexible sleeve into a body lumen or vasculature”, and Col. 5, lines 34-43, “The processing system 100 further comprises a registration program 134 stored on the memory 130 and executed by the processor 110 to register a coordinate system for the shape sensing system 10 to a coordinate system for pre-procedural or intra procedural imaging data. The imaging data may be stored imaging data or real-time imaging data from an MRI, X-ray, ultrasound, or any other type of imaging system appropriate for acquiring images of anatomic structures. According to one embodiment, the imaging system data comprises a three-dimensional image volume”);
inserting the device (10) in the passage to begin navigating the device (10) through the passage at an initial position (see, e.g., Col. 4, lines 26-47, “The shape sensing system 10 comprises a shape sensing fiber 212 disposed in or affixed to a surgical instrument 200. The instrument 200 may be any instrument used during an intervention, including but not limited to: a mechanical scalpel (lancet), a laser scalpel, an endoscope, microscopic imaging probes, a surgical stapler, a retractor, a cautery device (electrical or optical), a catheter, a chisel, a clamp, a probe, a trocar, scissors, or the like. The instrument 200 may be manipulated by a physician to perform an intervention procedure. […] The instrument 200 may be introduced endoluminally or endovascularly into a patient through an introducer 220, which may comprise one or more flexible and/or rigid sleeves, through which the instrument 200 may be advanced and/or retracted. According to one embodiment, shown in FIGS. 2 and 3, the instrument 200 is disposed in a flexible sleeve 222 which is disposed in a shorter rigid sleeve 224 used to introduce the instrument and flexible sleeve into a body lumen or vasculature”);
at an initial times, registering the initial position of the device (10) and the planned path in a 3D shape space, and determining an initial transformation algorithm using the registration in the 3D shape space to transform the initial position of the device (10) to a 3D region space of the previously obtained 3D representation of the region of interest (see, e.g., Col. 6, lines 1-9, “the registration program 134 performs an initial alignment of the coordinate system of the shape sensing system 10 to a coordinate system from pre-procedural or intra-procedural imaging data (Step 410). The initial registration may be performed using any of a variety of known methods. For example, the initial registration may be performed by touching the shape sensing enabled instrument to a fiducial or an anatomical landmark corresponding to identifiable points in the imaging data”);
at subsequent times, while continuing to navigate the device (10) through the passage, applying the initial transformation algorithm to the device (10) to iteratively transform subsequent positions of the device (10), determined using the at least one EM sensor, corresponding to the subsequent times from the 3D shape space into the 3D region space (see, e.g., Col. 6, lines 10-17, “The registration program 134 determines a stable curvature (step 420). To determine a stable curvature, the registration program first identifies a curve in the shape sensing fiber 212. The shape sensing fiber 212 provides a polyline curve 500, as shown in FIG. 5. The polyline curve is a curve formed by multiple points (corresponding to the sensor locations) with each point subsequent on the shape sensing fiber 212 to the previous point”, and Col. 7, lines 53-55, “The storage device can be an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system (or apparatus or device)”);
determining a best overlapping region between the planned path and the subsequent positions of the device (10) in the 3D region space, the best overlapping region comprising a portion of the previously obtained 3D representation of the region of interest in which the subsequent positions of the device (10) most closely coincide with the planned path (see, e.g., Col. 6, lines 35-52, “The registration program 134 compares curvatures temporally (i.e., over subsequent shape reconstructions) to check that a bend is stable (Step 422). For clinical purposes, a bend as distally located along the shape as possible is preferred, because the displacement of tip of the instrument with respect to the bend will be minimized. If the distance from the origin of the shape to a stable physical constraint on the instrument (and shape sensing fiber) is known, for example by using a curved introducer, the search window for bend radii can be limited to positions at the geodesic distance for the known stable physical constraint. The registration program determines whether or not the curvature or bend is stable (Step 425). If the bend radii from subsequent shape reconstructions match within a predetermined margin of error the curvature is determined to be stable (Y branch from step 4125). If the curvature is not stable (N branch from step 425) additional bends are tested (Step 421)”, where the best overlapping region includes the region in which the curvature is determined to be stable);
registering the subsequent positions of the device (10) only in the best overlapping region and the planned path only in the best overlapping region in the 3D space shape, and determining an updated transformation algorithm using the subsequent registration in the best overlapping region (see, e.g., Col. 6, lines 53-67 and Col. 7, lines 1-19, “Returning to FIG. 4, once a stable curvature is determined (Step 420), curvatures are matched to the stable curvature from another source (Step 430). The other source may be another shape reconstruction from a different time. Alternatively, the other source may be data from pre-procedural or intra-procedural imaging, such as an anatomical volume reconstruction from computer tomography. In another embodiment the other source may be a different shape sensing fiber subject to the same shape constraint as the first shape sensing fiber. The curvatures are matched by comparing the bend radii from the different curvatures of different curves as shown in FIG. 6. The bend radius of the curve 500 (stored from step 420) defined by points 501, 502, 503 is matched to the bend radius of curve 600 (from a different source) defined by points 610, 602, 603. If the bend radii match within a predetermined margin of error, then the curvatures are determined to match. Because the points lie at discrete distances, the curve of the new shape may have shifted between positions of the reference shape. […] The registration program 134 aligns the matching curvatures (Step 440). A translation and rotation are calculated to bring the three-dimensional curvature from the different source with matching bend radius into alignment with the three-dimensional curvature from the stored stable curvature. The translation and rotation needed for alignment may be expressed in the form of a transformation matrix, which may be applied to the shape reconstruction to align it to the imaging data. The matrix may be calculated from coordinates of points on the matching curvatures”, where the updated transformation corresponds to the disclosed transformation matrix); and
applying the updated transformation algorithm to the device (10) to again transform the subsequent positions of the device (10), determined using the at least one EM sensor when the device (10) is said interventional device, from the 3D shape space into the 3D region space (see, e.g., Col. 7, lines 15-19, “The translation and rotation needed for alignment may be expressed in the form of a transformation matrix, which may be applied to the shape reconstruction to align it to the imaging data. The matrix may be calculated from coordinates of points on the matching curvatures”, where the updated transformation corresponds to the disclosed transformation matrix that is applied to the reconstruction, and Col. 7, lines 53-55, “The storage device can be an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system (or apparatus or 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 for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Denissen (US Patent 9,430,717 B2), as applied to claims 16-17 above, in view of Fisker et al. (US 2014/0022352 A1, of record, hereinafter Fisker).
Regarding claim 18, Denissen discloses the system of claim 17. Denissen does not disclose wherein said registration algorithm specifically comprises a deformable Iterative Closest Point (ICP) algorithm.
However, in the same field of endeavor of registering and aligning optical images/scan points, Fisker discloses wherein said registration algorithm comprises a deformable Iterative Closest Point (ICP) algorithm (see, e.g., Para. [0128-0129], “In some embodiments the motion between at least two subsequent 3D surfaces are determined by aligning/registering the at least two subsequent 3D surfaces. This may be performed by means of the method of iterative closest point (ICP) or similar methods. The method of Iterative Closest Point (ICP) can be used for aligning, and it is employed to minimize the difference between two clouds of points. ICP can be used to reconstruct 2D or 3D surfaces from different scan. ICP iteratively revises the transformation, i.e. translation or rotation, needed to minimize the distance between the points of two raw scans. The input for ICP may be points from two raw scans, initial estimation of the transformation, and criteria for stopping the iteration. The output will thus be a refined transformation”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Denissen by including wherein said registration algorithm comprises a deformable Iterative Closest Point (ICP) algorithm, as disclosed by Fisker. One of ordinary skill in the art would have been motivated to make this modification in order to provide the desired registration and aligning of partial scans based on the Iterative Closest Point class of algorithms, which can result in reduced computation time, as recognized by Fisker (see, e.g., Para. [0045] and [0128-0129]).
Response to Arguments
Applicant's arguments, see Remarks filed 09/02/2025, have been fully considered but they are not persuasive.
Regarding Denissen (US Patent 9,430,717 B2), Applicant argues that the Examiner’s interpretation “does not support a finding that Denissen teaches or suggests a force sensing region having a force sensing distal end disposed proximal to the distal end of the outer body as set forth in claim [16]”, and therefore, “Applicant respectfully requests reconsideration and withdrawal of the rejection of claim 16”, as set forth in Pages 8-9 of the Remarks filed 09/02/2025.
Examiner respectfully disagrees and emphasizes that Denissen does disclose each and every limitation in the amended independent claim 16 (and similarly the other independent claims), as set forth above.
Specifically, Examiner emphasizes that Denissen discloses the force sensing region (plurality of optical scatterers of shape sensing fiber 212) configured for sensing an amount of axial forces exerted on a distal end of the outer body (surgical instrument 200, flexible sleeve 222), and the force sensing region (plurality of optical scatterers of shape sensing fiber 212) having a force sensing distal end disposed proximal to the distal end of the outer body (200, 222) (see, e.g., Col. 4, lines 48-67 and Col. 5, lines 1-4, “The shape sensing fiber 212, together with an optical console 210, forms a shape sensing system 10 that provides strain information. The optical console 210 is operably connected to the shape sensing fiber 212. For example, the shape sensing fiber 212 may be connected to the optical console at an optical connector. The shape sensing fiber 212 is an optical fiber. A plurality of optical scatterers (e.g. Fiber Bragg Gratings or Rayleigh scatterers) may be distributed over the length of the optical fiber in the core or cladding to form sensors or gauges to measure strain. The optical console 210 interrogates the optical fiber, sending a broadband light signal along the optical fiber core and measuring the reflected wavelengths to determine length-resolved strain in the optical fiber core. Alternatively, the reflection spectrum may be obtained from a narrow band light source whereby the wavelength is swept in time. The strain data is then used to calculate the local curvature at each sensor, and the curvature data is compiled to calculate a three-dimensional shape of the shape sensing fiber 212, which corresponds to the shape of the instrument in which the shape sensing fiber is disposed or to which the shape sensing fiber is affixed. The optical console 210 may include a processor and may process the wavelength and strain data from the sensors” (emphasis herein added), where length-resolved strain (i.e., axial force applied in the lengthwise direction) in the optical fiber core is determined/measured by the plurality of optical scatterers that are distributed over the length of the optical fiber 212 in the core at the distal end of the instrument 200 in which the shape sensing fiber 212 is disposed or affixed to, such that the plurality of optical scatterers distributed over the length of the optical fiber 212 in the core at the distal end of the instrument 200 would be positioned proximal to the most distal end/tip of the instrument 200).
Therefore, Denissen does disclose each and every limitation in the amended independent claim 16 (and similarly the other independent claims), as set forth above.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/T.D./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798