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.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The terms “portion” and “part of” in claims 1, 3, 6-11, 17 and 19 are relative terms which renders the claim indefinite. The term “portion” and “part of” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much shape information is encompassed by a portion of derived shape information.
Claim Rejections - 35 USC § 102
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 1-13, and 15-19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Duindam et al (US20190175060A1; hereinafter referred to as Duindam).
Regarding Claim 1, Duindam discloses a computer implemented method for determining the position of one or more points of an elongated medical device in a channel inside an object (“A medical system comprises a flexible instrument including a sensor adapted to provide tracking data for a point on the instrument.” [Abstract], “ flexible body 124 can define one or more lumens through which surgical instruments can be deployed and used at a target surgical location” [0032]), the method comprising:
Obtaining, using a processor, three-dimensional image data of an inside of the object comprising at least data of a channel of interest inside the object (“he system also comprises a processor that identifies connected anatomical structures in the stored images of the patient anatomy and generates a plurality of cylindrical linkage elements representing the connected anatomical structures. The processor also receives the tracking data corresponding to the point on an instrument positioned within at least one of the connected anatomical structures and matches the point on the instrument to one of the plurality of cylindrical linkage elements. “ [0006], “monitor 111 may present images of the surgical site recorded and/or modeled preoperatively using imaging technology such as… The presented preoperative images may include two-dimensional, three-dimensional, or four-dimensional images” [0026], “FIG. 4 is a three dimensional model 200 of a portion of bronchial structure 202 of a lung as captured in preoperative image. The bronchial structure 202 includes discrete bronchial passageways 204-216. A series of centerpoints through the bronchial passageways 204-216 form the anatomic centerline 218.” [0048]),
deriving, using a processor, based on the obtained three-dimensional image data derived shape information for at least part of the channel of interest (“FIG. 4 is a three dimensional model 200 of a portion of bronchial structure 202 of a lung as captured in preoperative image. The bronchial structure 202 includes discrete bronchial passageways 204-216. A series of centerpoints through the bronchial passageways 204-216 form the anatomic centerline 218. The image 200 may be a composite image formed from a plurality of preoperative images. FIG. 5 is an illustration 300 of a three dimensional linked structure 302 of cylindrical linkage elements 304-316 representing the bronchial passageways 204-216.” [0048]),
deriving, for positions along the channel of interest and using a processor,, a confinement parameter expressing whether the elongated medical device will be confined at those positions in the channel of interest (“At step 410, the point P is evaluated to determine whether it is outside a cylindrical linkage element or inside a cylindrical linkage element. If the point P is inside the cylindrical linkage element, at step 412, the rendered image of the point P on the instrument image is maintained within the bronchial passage on the co-registered lung image. If the point P is outside the cylindrical linkage element, at step 414, the rendered image of the point P on the instrument image is adjusted or snapped to the point PS along the projection between P and Pf where the projection intersects the wall of the bronchial passage. At step 416, a corrected image composite image 150 depicting the image 151 of a human lung 152 registered with an corrected instrument image 154 is prepared. In the corrected images, the point P is snapped to the bronchial passageway rather than extending outside the bronchial wall.” [0056]),
obtaining, using a processor, measured shape information of an elongated medical device based on optical signals obtained from a multicore fiber coupled to the elongated medical device, for determining shape information of the elongated medical device (“The sensor system 138 includes an optical fiber 140 aligned with the flexible body 124 (e.g., provided within an interior channel (not shown) or mounted externally). The tracking system 135 is coupled to a proximal end of the optical fiber 140. In this embodiment, the fiber 140 has a diameter of approximately 200 μm. In other embodiments, the dimensions may be larger or smaller.” [0036], “The optical fiber 140 forms a fiber optic bend sensor for determining the shape of the instrument 120.” [0037]),
and determining, using a processor, a position of one or more points of the elongated medical device with respect to the three-dimensional image data or a portion thereof by mapping a portion of the measured shape information of the elongated medical device with a portion of the derived shape information for at least part of the channel of interest, the portion of the derived shape information corresponding with positions where the elongated medical device is confined in the channel of interest, based on the confinement parameter ; wherein mapping is performed only for portions of the channel of interest in which the elongated device is confined (“FIG. 7 is a flowchart 400 illustrating a method for snapping a three dimensional point P of the instrument 154 to a bronchial passageway. This method may be used to correct the image of the instrument at point P when, for example as shown in FIG. 3a , the tracking system information, including information from a shape sensor and/or an EM sensor, positions a portion of the instrument, including point P, outside of a bronchial passageway.” [0051], “At step 410, the point P is evaluated to determine whether it is outside a cylindrical linkage element or inside a cylindrical linkage element. If the point P is inside the cylindrical linkage element, at step 412, the rendered image of the point P on the instrument image is maintained within the bronchial passage on the co-registered lung image. If the point P is outside the cylindrical linkage element, at step 414, the rendered image of the point P on the instrument image is adjusted or snapped to the point PS along the projection between P and Pf where the projection intersects the wall of the bronchial passage. At step 416, a corrected image composite image 150 depicting the image 151 of a human lung 152 registered with an corrected instrument image 154 is prepared. In the corrected images, the point P is snapped to the bronchial passageway rather than extending outside the bronchial wall.” [0056]).
Regarding Claim 2, Duindam discloses the method furthermore comprising, based on said determining a position, showing said determined position of one or more points of the elongated medical device with respect to the three-dimensional image data (“FIG. 7 is a flowchart 400 illustrating a method for snapping a three dimensional point P of the instrument 154 to a bronchial passageway. This method may be used to correct the image of the instrument at point P when, for example as shown in FIG. 3a , the tracking system information, including information from a shape sensor and/or an EM sensor, positions a portion of the instrument, including point P, outside of a bronchial passageway.” [0051], “At step 410, the point P is evaluated to determine whether it is outside a cylindrical linkage element or inside a cylindrical linkage element. If the point P is inside the cylindrical linkage element, at step 412, the rendered image of the point P on the instrument image is maintained within the bronchial passage on the co-registered lung image. If the point P is outside the cylindrical linkage element, at step 414, the rendered image of the point P on the instrument image is adjusted or snapped to the point PS along the projection between P and Pf where the projection intersects the wall of the bronchial passage. At step 416, a corrected image composite image 150 depicting the image 151 of a human lung 152 registered with an corrected instrument image 154 is prepared. In the corrected images, the point P is snapped to the bronchial passageway rather than extending outside the bronchial wall.” [0056]).
Regarding Claim 3, Duindam discloses deriving the confinement parameter comprises indicating that the channel of interest is confined for positions where the channel width is smaller than four times the width of the elongated medical device and selecting these portions for use (“FIG. 7 is a flowchart 400 illustrating a method for snapping a three dimensional point P of the instrument 154 to a bronchial passageway. This method may be used to correct the image of the instrument at point P when, for example as shown in FIG. 3a , the tracking system information, including information from a shape sensor and/or an EM sensor, positions a portion of the instrument, including point P, outside of a bronchial passageway.” [0051], “At step 410, the point P is evaluated to determine whether it is outside a cylindrical linkage element or inside a cylindrical linkage element. If the point P is inside the cylindrical linkage element, at step 412, the rendered image of the point P on the instrument image is maintained within the bronchial passage on the co-registered lung image. If the point P is outside the cylindrical linkage element, at step 414, the rendered image of the point P on the instrument image is adjusted or snapped to the point PS along the projection between P and Pf where the projection intersects the wall of the bronchial passage. At step 416, a corrected image composite image 150 depicting the image 151 of a human lung 152 registered with an corrected instrument image 154 is prepared. In the corrected images, the point P is snapped to the bronchial passageway rather than extending outside the bronchial wall.” [0056], it is known in the art that bronchial airways get as small as 0.5 mm therefore it is inherent that during imaging of bronchial airways the width of the channel is four times smaller than the medical device).
Regarding Claim 4, Duindam discloses deriving the confinement parameter based on the channel width is performed using the three-dimensional image data (“FIG. 7 is a flowchart 400 illustrating a method for snapping a three dimensional point P of the instrument 154 to a bronchial passageway. This method may be used to correct the image of the instrument at point P when, for example as shown in FIG. 3a , the tracking system information, including information from a shape sensor and/or an EM sensor, positions a portion of the instrument, including point P, outside of a bronchial passageway.” [0051], “At step 410, the point P is evaluated to determine whether it is outside a cylindrical linkage element or inside a cylindrical linkage element. If the point P is inside the cylindrical linkage element, at step 412, the rendered image of the point P on the instrument image is maintained within the bronchial passage on the co-registered lung image. If the point P is outside the cylindrical linkage element, at step 414, the rendered image of the point P on the instrument image is adjusted or snapped to the point PS along the projection between P and Pf where the projection intersects the wall of the bronchial passage. At step 416, a corrected image composite image 150 depicting the image 151 of a human lung 152 registered with an corrected instrument image 154 is prepared. In the corrected images, the point P is snapped to the bronchial passageway rather than extending outside the bronchial wall.” [0056]).
Regarding Claim 5, Duindam discloses at positions along the channel of interest where the channel of interest is not confined according to the confinement parameter, the orientation of the elongated medical device is derived from the measured shape information measured using the multicore fiber (“The optical fiber 140 forms a fiber optic bend sensor for determining the shape of the instrument 120. In one alternative, optical fibers including Fiber Bragg Gratings (FBGs) are used to provide strain measurements in structures in one or more dimensions. Various systems and methods for monitoring the shape and relative position of a optical fiber in three dimensions are described” [0037], “A tracking system 135 includes an electromagnetic (EM) sensor system 136 and a shape sensor system 138 for determining the position, orientation, speed, pose, and/or shape of the distal end 128 and of one or more segments 137 along the instrument 120.” [0034]).
Regarding Claim 6, Duindam discloses said determining the position of one or more points of the elongated medical device comprises determining the position of one or more points of the elongated medical device based on said mapping for the portion of the channel of interest wherein the elongated medical device is confined and determining a position of one or more additional points of the elongated medical device for points where the elongated medical device is not confined in the channel of interest from the measured shape information (“FIG. 7 is a flowchart 400 illustrating a method for snapping a three dimensional point P of the instrument 154 to a bronchial passageway. This method may be used to correct the image of the instrument at point P when, for example as shown in FIG. 3a , the tracking system information, including information from a shape sensor and/or an EM sensor, positions a portion of the instrument, including point P, outside of a bronchial passageway.” [0051], “At step 410, the point P is evaluated to determine whether it is outside a cylindrical linkage element or inside a cylindrical linkage element. If the point P is inside the cylindrical linkage element, at step 412, the rendered image of the point P on the instrument image is maintained within the bronchial passage on the co-registered lung image. If the point P is outside the cylindrical linkage element, at step 414, the rendered image of the point P on the instrument image is adjusted or snapped to the point PS along the projection between P and Pf where the projection intersects the wall of the bronchial passage. At step 416, a corrected image composite image 150 depicting the image 151 of a human lung 152 registered with an corrected instrument image 154 is prepared. In the corrected images, the point P is snapped to the bronchial passageway rather than extending outside the bronchial wall.” [0056]).
Regarding Claim 7, Duindam discloses that the portion of the channel of interest wherein the elongated medical device is confined is a single contiguous portion, and whereby a portion of the channel of interest wherein the elongated medical device is not confined, corresponds to free space (“FIG. 7 is a flowchart 400 illustrating a method for snapping a three dimensional point P of the instrument 154 to a bronchial passageway. This method may be used to correct the image of the instrument at point P when, for example as shown in FIG. 3a , the tracking system information, including information from a shape sensor and/or an EM sensor, positions a portion of the instrument, including point P, outside of a bronchial passageway.” [0051], “At step 410, the point P is evaluated to determine whether it is outside a cylindrical linkage element or inside a cylindrical linkage element. If the point P is inside the cylindrical linkage element, at step 412, the rendered image of the point P on the instrument image is maintained within the bronchial passage on the co-registered lung image. If the point P is outside the cylindrical linkage element, at step 414, the rendered image of the point P on the instrument image is adjusted or snapped to the point PS along the projection between P and Pf where the projection intersects the wall of the bronchial passage. At step 416, a corrected image composite image 150 depicting the image 151 of a human lung 152 registered with an corrected instrument image 154 is prepared. In the corrected images, the point P is snapped to the bronchial passageway rather than extending outside the bronchial wall.” [0056]).
Regarding Claim 8, Duindam discloses the method comprises determining a position of the end point of the elongated medical device being in free space, said determining being based on mapping of a portion of the elongated medical device where it is confined in the channel of interest and on the measured shape information for the portion of the elongated medical device where it is not confined in the channel of interest (“A tracking system 135 includes an electromagnetic (EM) sensor system 136 and a shape sensor system 138 for determining the position, orientation, speed, pose, and/or shape of the distal end 128 and of one or more segments 137 along the instrument 120.” [0034], “FIG. 7 is a flowchart 400 illustrating a method for snapping a three dimensional point P of the instrument 154 to a bronchial passageway. This method may be used to correct the image of the instrument at point P when, for example as shown in FIG. 3a , the tracking system information, including information from a shape sensor and/or an EM sensor, positions a portion of the instrument, including point P, outside of a bronchial passageway.” [0051], “At step 410, the point P is evaluated to determine whether it is outside a cylindrical linkage element or inside a cylindrical linkage element. If the point P is inside the cylindrical linkage element, at step 412, the rendered image of the point P on the instrument image is maintained within the bronchial passage on the co-registered lung image. If the point P is outside the cylindrical linkage element, at step 414, the rendered image of the point P on the instrument image is adjusted or snapped to the point PS along the projection between P and Pf where the projection intersects the wall of the bronchial passage. At step 416, a corrected image composite image 150 depicting the image 151 of a human lung 152 registered with an corrected instrument image 154 is prepared. In the corrected images, the point P is snapped to the bronchial passageway rather than extending outside the bronchial wall.” [0056]).
Regarding Claim 9, Duindam discloses the portion of the channel of interest wherein the elongated medical device is confined corresponds with two or more non- contiguous regions (“FIG. 4 is a three dimensional model 200 of a portion of bronchial structure 202 of a lung as captured in preoperative image. The bronchial structure 202 includes discrete bronchial passageways 204-216. A series of centerpoints through the bronchial passageways 204-216 form the anatomic centerline 218. The image 200 may be a composite image formed from a plurality of preoperative images. FIG. 5 is an illustration 300 of a three dimensional linked structure 302 of cylindrical linkage elements 304-316 representing the bronchial passageways 204-216.” [0048], “FIG. 7 is a flowchart 400 illustrating a method for snapping a three dimensional point P of the instrument 154 to a bronchial passageway. This method may be used to correct the image of the instrument at point P when, for example as shown in FIG. 3a , the tracking system information, including information from a shape sensor and/or an EM sensor, positions a portion of the instrument, including point P, outside of a bronchial passageway.” [0051], “At step 410, the point P is evaluated to determine whether it is outside a cylindrical linkage element or inside a cylindrical linkage element. If the point P is inside the cylindrical linkage element, at step 412, the rendered image of the point P on the instrument image is maintained within the bronchial passage on the co-registered lung image. If the point P is outside the cylindrical linkage element, at step 414, the rendered image of the point P on the instrument image is adjusted or snapped to the point PS along the projection between P and Pf where the projection intersects the wall of the bronchial passage. At step 416, a corrected image composite image 150 depicting the image 151 of a human lung 152 registered with an corrected instrument image 154 is prepared. In the corrected images, the point P is snapped to the bronchial passageway rather than extending outside the bronchial wall.” [0056], see Fig. 4 and 5 for non-contiguous bronchial passageways).
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Regarding Claim 10, Duindam discloses obtaining the derived shape information of the portion of a channel of interest and/or obtaining the measured shape information of a portion of an elongated medical device comprises obtaining information of a curvature parameter as function of a length along that portion of a channel of interest or along that portion of an elongated medical device (“The optical fiber 140 forms a fiber optic bend sensor for determining the shape of the instrument 120. In one alternative, optical fibers including Fiber Bragg Gratings (FBGs) are used to provide strain measurements in structures in one or more dimensions. Various systems and methods for monitoring the shape and relative position of a optical fiber in three dimensions” [0037], “By having two or more cores disposed off-axis in the fiber, bending of the fiber induces different strains on each of the cores. These strains are a function of the local degree of bending of the fiber. For example, regions of the cores containing FBG's, if located at points where the fiber is bent, can thereby be used to determine the amount of bending at those points. These data, combined with the known spacings of the FBG regions, can be used to reconstruct the shape of the fiber.” [0041]).
Regarding Claim 11, Duindam discloses determining the position of one or more points of the elongated medical device with respect to the three-dimensional image data comprises: determining, for a plurality of channels of the three-dimensional image data, the difference between at least a portion of the measured shape information and at least a portion of the derived shape information of the channel, identifying the channel of the three-dimensional image data showing the smallest difference between the at least portion of the measured shape information and the at least portion of the derived shape information, and matching the position of the elongated medical device with the position of the identified channel (“FIG. 7 is a flowchart 400 illustrating a method for snapping a three dimensional point P of the instrument 154 to a bronchial passageway. This method may be used to correct the image of the instrument at point P when, for example as shown in FIG. 3a , the tracking system information, including information from a shape sensor and/or an EM sensor, positions a portion of the instrument, including point P, outside of a bronchial passageway.” [0051], “At step 410, the point P is evaluated to determine whether it is outside a cylindrical linkage element or inside a cylindrical linkage element. If the point P is inside the cylindrical linkage element, at step 412, the rendered image of the point P on the instrument image is maintained within the bronchial passage on the co-registered lung image. If the point P is outside the cylindrical linkage element, at step 414, the rendered image of the point P on the instrument image is adjusted or snapped to the point PS along the projection between P and Pf where the projection intersects the wall of the bronchial passage. At step 416, a corrected image composite image 150 depicting the image 151 of a human lung 152 registered with an corrected instrument image 154 is prepared. In the corrected images, the point P is snapped to the bronchial passageway rather than extending outside the bronchial wall.” [0056]).
Regarding Claim 12, Duindam discloses the plurality of channels represents different branches of a branched channel of interest (“FIG. 4 is a three dimensional model 200 of a portion of bronchial structure 202 of a lung as captured in preoperative image. The bronchial structure 202 includes discrete bronchial passageways 204-216. A series of centerpoints through the bronchial passageways 204-216 form the anatomic centerline 218. The image 200 may be a composite image formed from a plurality of preoperative images. FIG. 5 is an illustration 300 of a three dimensional linked structure 302 of cylindrical linkage elements 304-316 representing the bronchial passageways 204-216.” [0048], see Fig. 4 and 5 for branched channels).
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Regarding Claim 13, Duindam discloses obtaining three-dimensional image data of an inside of the body comprises capturing a computed tomography scan of the object (“monitor 111 may present images of the surgical site recorded and/or modeled preoperatively using imaging technology such as, computerized tomography (CT)” [0026]).
Regarding Claim 15, Duindam discloses the multicore fiber is a fiber comprising a plurality of cores, at least two cores having a plurality of Bragg gratings inscribed, the plurality of Bragg gratings being spaced apart from each other and being positioned along the length of the multicore fiber (“When applied to a multicore fiber, bending of the optical fiber induces strain on the cores that can be measured by monitoring the wavelength shifts in each core. By having two or more cores disposed off-axis in the fiber, bending of the fiber induces different strains on each of the cores. These strains are a function of the local degree of bending of the fiber. For example, regions of the cores containing Fiber Bragg Gratings (FBG), if located at points where the fiber is bent, can thereby be used to determine the amount of bending at those points. These data, combined with the known spacings of the FBG regions, can be used to reconstruct the shape of the fiber.” [0041]).
Regarding Claim 16, Duindam discloses the method furthermore comprises a data output, an auditive output or a visual output for outputting information regarding one or more positions of the elongated medical device with respect to a coordinate system of the body or an image thereof (“A display system 111 may display an image of the surgical site and surgical instruments captured by the visualization system 110.” [0025]).
Regarding Claim 17, Duindam discloses a system for determining a position of an elongated medical device in an object (“A medical system comprises a flexible instrument including a sensor adapted to provide tracking data for a point on the instrument.” [Abstract], “ flexible body 124 can define one or more lumens through which surgical instruments can be deployed and used at a target surgical location” [0032]), the system comprising:
a data input port for obtaining three-dimensional image data of an inside of the object comprising at least data of a channel of interest inside the object (“monitor 111 may present images of the surgical site recorded and/or modeled preoperatively using imaging technology such as… The presented preoperative images may include two-dimensional, three-dimensional, or four-dimensional images” [0026], “FIG. 4 is a three dimensional model 200 of a portion of bronchial structure 202 of a lung as captured in preoperative image. The bronchial structure 202 includes discrete bronchial passageways 204-216. A series of centerpoints through the bronchial passageways 204-216 form the anatomic centerline 218.” [0048]),
and for obtaining optical signals obtained from a multicore fiber coupled to the elongated medical device in the object (“The sensor system 138 includes an optical fiber 140 aligned with the flexible body 124 (e.g., provided within an interior channel (not shown) or mounted externally). The tracking system 135 is coupled to a proximal end of the optical fiber 140. In this embodiment, the fiber 140 has a diameter of approximately 200 μm. In other embodiments, the dimensions may be larger or smaller.” [0036], “The optical fiber 140 forms a fiber optic bend sensor for determining the shape of the instrument 120.” [0037]),
a processor programmed to obtain three-dimensional image data of at least the channel of interest (“As shown in FIG. 1, a control system 116 includes at least one processor and typically a plurality of processors for effecting control between the surgical manipulator assembly 102, the master assembly 106, and the image and display system 110.” [0029], “monitor 111 may present images of the surgical site recorded and/or modeled preoperatively using imaging technology such as… The presented preoperative images may include two-dimensional, three-dimensional, or four-dimensional images” [0026], “FIG. 4 is a three dimensional model 200 of a portion of bronchial structure 202 of a lung as captured in preoperative image. The bronchial structure 202 includes discrete bronchial passageways 204-216. A series of centerpoints through the bronchial passageways 204-216 form the anatomic centerline 218.” [0048])
and for deriving based on the obtained three-dimensional image data derived shape information for at least part of the channel of interest (“FIG. 4 is a three dimensional model 200 of a portion of bronchial structure 202 of a lung as captured in preoperative image. The bronchial structure 202 includes discrete bronchial passageways 204-216. A series of centerpoints through the bronchial passageways 204-216 form the anatomic centerline 218. The image 200 may be a composite image formed from a plurality of preoperative images. FIG. 5 is an illustration 300 of a three dimensional linked structure 302 of cylindrical linkage elements 304-316 representing the bronchial passageways 204-216.” [0048]),
and for deriving a confinement parameter expressing whether the elongated medical device will be confined at those positions in the channel of interest (“At step 410, the point P is evaluated to determine whether it is outside a cylindrical linkage element or inside a cylindrical linkage element. If the point P is inside the cylindrical linkage element, at step 412, the rendered image of the point P on the instrument image is maintained within the bronchial passage on the co-registered lung image. If the point P is outside the cylindrical linkage element, at step 414, the rendered image of the point P on the instrument image is adjusted or snapped to the point PS along the projection between P and Pf where the projection intersects the wall of the bronchial passage. At step 416, a corrected image composite image 150 depicting the image 151 of a human lung 152 registered with an corrected instrument image 154 is prepared. In the corrected images, the point P is snapped to the bronchial passageway rather than extending outside the bronchial wall.” [0056]),
the processor being programmed for obtaining measured shape information of an elongated medical device based on the obtained optical signals (“The sensor system 138 includes an optical fiber 140 aligned with the flexible body 124 (e.g., provided within an interior channel (not shown) or mounted externally). The tracking system 135 is coupled to a proximal end of the optical fiber 140. In this embodiment, the fiber 140 has a diameter of approximately 200 μm. In other embodiments, the dimensions may be larger or smaller.” [0036], “The optical fiber 140 forms a fiber optic bend sensor for determining the shape of the instrument 120.” [0037]),
the processor furthermore being programmed for determining a position of one or more points of the elongated medical device with respect to the three-dimensional image data or a portion thereof by mapping a portion of the measured shape information of the elongated medical device with a portion of the derived shape information for at least part of the channel of interest, the portion of the derived shape information corresponding with positions where the elongated medical device is confined in the channel of interest, based on the confinement parameter wherein mapping is performed only for portions of the channel of interest in which the elongated device is confined (“FIG. 7 is a flowchart 400 illustrating a method for snapping a three dimensional point P of the instrument 154 to a bronchial passageway. This method may be used to correct the image of the instrument at point P when, for example as shown in FIG. 3a , the tracking system information, including information from a shape sensor and/or an EM sensor, positions a portion of the instrument, including point P, outside of a bronchial passageway.” [0051], “At step 410, the point P is evaluated to determine whether it is outside a cylindrical linkage element or inside a cylindrical linkage element. If the point P is inside the cylindrical linkage element, at step 412, the rendered image of the point P on the instrument image is maintained within the bronchial passage on the co-registered lung image. If the point P is outside the cylindrical linkage element, at step 414, the rendered image of the point P on the instrument image is adjusted or snapped to the point PS along the projection between P and Pf where the projection intersects the wall of the bronchial passage. At step 416, a corrected image composite image 150 depicting the image 151 of a human lung 152 registered with an corrected instrument image 154 is prepared. In the corrected images, the point P is snapped to the bronchial passageway rather than extending outside the bronchial wall.” [0056]).
Regarding Claim 18, Duindam discloses the system furthermore comprising a graphical user interface for outputting a position of one or more points of the elongated medical device with respect to at least part of the three-dimensional image (“the monitor 111 may display a virtual navigational image in which the actual location of the surgical instrument is registered (i.e., dynamically referenced) with preoperative or concurrent images to present the surgeon S with a virtual image of the internal surgical site at the location of the tip of the surgical instrument. An image of the tip of the surgical instrument or other graphical or alphanumeric indicators may be superimposed on the virtual image to assist the surgeon controlling the surgical instrument.” [0027]).
Regarding Claim 19, Duindam discloses a non-transitory computer program product adapted for, when run on a processor, performing the steps of a method for assisting in guiding an elongated medical device in an object (“A medical system comprises a flexible instrument including a sensor adapted to provide tracking data for a point on the instrument.” [Abstract], “The visualization system 110 may be implemented as hardware, firmware, software or a combination thereof which interact with or are otherwise executed by one or more computer processors, which may include the processors of a control system 116 (described below).” [0024], “ flexible body 124 can define one or more lumens through which surgical instruments can be deployed and used at a target surgical location” [0032]), the method comprising:
obtaining three-dimensional image data of an inside of the object comprising at least data of a channel of interest inside the object (“monitor 111 may present images of the surgical site recorded and/or modeled preoperatively using imaging technology such as… The presented preoperative images may include two-dimensional, three-dimensional, or four-dimensional images” [0026], “FIG. 4 is a three dimensional model 200 of a portion of bronchial structure 202 of a lung as captured in preoperative image. The bronchial structure 202 includes discrete bronchial passageways 204-216. A series of centerpoints through the bronchial passageways 204-216 form the anatomic centerline 218.” [0048]),
deriving based on the obtained three-dimensional image data derived shape information for at least part of the channel of interest (“FIG. 4 is a three dimensional model 200 of a portion of bronchial structure 202 of a lung as captured in preoperative image. The bronchial structure 202 includes discrete bronchial passageways 204-216. A series of centerpoints through the bronchial passageways 204-216 form the anatomic centerline 218. The image 200 may be a composite image formed from a plurality of preoperative images. FIG. 5 is an illustration 300 of a three dimensional linked structure 302 of cylindrical linkage elements 304-316 representing the bronchial passageways 204-216.” [0048]),
deriving, for positions along the channel of interest, a confinement parameter expressing whether the elongated medical device will be confined at those positions in the channel of interest (“At step 410, the point P is evaluated to determine whether it is outside a cylindrical linkage element or inside a cylindrical linkage element. If the point P is inside the cylindrical linkage element, at step 412, the rendered image of the point P on the instrument image is maintained within the bronchial passage on the co-registered lung image. If the point P is outside the cylindrical linkage element, at step 414, the rendered image of the point P on the instrument image is adjusted or snapped to the point PS along the projection between P and Pf where the projection intersects the wall of the bronchial passage. At step 416, a corrected image composite image 150 depicting the image 151 of a human lung 152 registered with an corrected instrument image 154 is prepared. In the corrected images, the point P is snapped to the bronchial passageway rather than extending outside the bronchial wall.” [0056]),
obtaining measured shape information of an elongated medical device based on optical signals obtained from a multicore fiber coupled to the elongated medical device, for determining shape information of the elongated medical device (“The sensor system 138 includes an optical fiber 140 aligned with the flexible body 124 (e.g., provided within an interior channel (not shown) or mounted externally). The tracking system 135 is coupled to a proximal end of the optical fiber 140. In this embodiment, the fiber 140 has a diameter of approximately 200 μm. In other embodiments, the dimensions may be larger or smaller.” [0036], “The optical fiber 140 forms a fiber optic bend sensor for determining the shape of the instrument 120.” [0037]),
and determining a position of one or more points of the elongated medical device with respect to the three-dimensional image data or a portion thereof by mapping a portion of the measured shape information of the elongated medical device with a portion of the derived shape information for at least part of the channel of interest, the portion of the derived shape information corresponding with positions where the elongated medical device is confined in the channel of interest, based on the confinement parameter, wherein mapping is performed only for portions of the channel of interest in which the elongated device is confined (“FIG. 7 is a flowchart 400 illustrating a method for snapping a three dimensional point P of the instrument 154 to a bronchial passageway. This method may be used to correct the image of the instrument at point P when, for example as shown in FIG. 3a , the tracking system information, including information from a shape sensor and/or an EM sensor, positions a portion of the instrument, including point P, outside of a bronchial passageway.” [0051], “At step 410, the point P is evaluated to determine whether it is outside a cylindrical linkage element or inside a cylindrical linkage element. If the point P is inside the cylindrical linkage element, at step 412, the rendered image of the point P on the instrument image is maintained within the bronchial passage on the co-registered lung image. If the point P is outside the cylindrical linkage element, at step 414, the rendered image of the point P on the instrument image is adjusted or snapped to the point PS along the projection between P and Pf where the projection intersects the wall of the bronchial passage. At step 416, a corrected image composite image 150 depicting the image 151 of a human lung 152 registered with an corrected instrument image 154 is prepared. In the corrected images, the point P is snapped to the bronchial passageway rather than extending outside the bronchial wall.” [0056]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over Duindam in view of Childers et al (US20060013523A1; hereinafter referred to as Childlers).
Regarding Claim 14, Duindam discloses all limitations noted above except that the length of the multicore fiber along which a plurality of optical sensing elements for obtaining the optical signals are positioned is 60cm or smaller.
However, in a similar field of endeavor, Childlers teaches a fiber optic position and shape sensing device [Abstract].
Childlers also teaches the length of the multicore fiber along which a plurality of optical sensing elements for obtaining the optical signals are positioned is 60cm or smaller (“Shape sensors wherein the optical fiber means comprises three single core optical fibers were surface attached to the outside of an inflatable isogrid boom that was approximately 1.2 m in length. The fiber optic sensor arrays, each containing approximately 120 sensors with a 0.5 cm gauge length spaced at 1 cm intervals” [0043]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Duindam as outlined above with the length of the multicore fiber along which a plurality of optical sensing elements for obtaining the optical signals are positioned is 60cm or smaller as taught by Childlers, because it provides the advantage of flexibility [0010].
Response to Arguments
Applicant's arguments filed 11/12/2025 have been fully considered but they are not persuasive.
Regarding the U.S.C. 112(b) rejections of Claim 1-19 the applicant recites the following:
The Applicant respectfully submits that the originally filed specification provides multiple examples that illustrate to one skilled in the art how much shape information is encompassed thereby. (See, e.g., paras. [0035]-[0041] and [0174]-[0178]).
However, it is noted, that the relative term “portion” also encompasses the amount of the channel that is being imaged and mapped which in the applicant’s specification is not readily defined. It remains unclear how much of the channel is being imaged to satisfy the remainder of the claim limitations.
Regarding the U.S.C. 103 rejections of Claim 1-19 the applicant recites the following:
Duindam does not disclose or suggest deriving such a confinement parameter, nor does it teach that mapping is limited to confined regions. As mentioned above, Duindam discloses a system designed to solve a problem of an incorrect rendering of an object on a screen. More particularly, as described in Duindam, "occasionally, the composite image 150 may erroneously render the instrument image 154 such that a portion of the instrument image 154' is outside of a bronchial passageway." (para. [0045] of Duindam). Selected points are then "snapped or graphically registered to a location on the wall of the anatomical passageway or to the lumen of the anatomical passageway" if they fall outside of the expected area as rendered on the screen. (para. [0047] of Duindam).
Thus, while Duindam describes the acquisition and use of image data, and identification of anatomical structures from these images, nothing in Duindam suggests that the instrument is physically confined, nor does Duindam disclose or suggest deriving a confinement parameter that expresses whether the device will be confined at a given position in the channel. Rather, Duindam focuses on correcting an incorrect graphical display. Duindam further fails to disclose or suggest performing the mapping only for portions of the channel of interest in which the elongated device is confined as required by the amended independent claims.
However, it is noted that under the broadest reasonable interpretation of Claim 1, all that is required is a measurement regarding whether the medical device is confined within a channel.
Duindam teaches using a combined imaging and tracking system to provide the position of an elongated medical device with the lungs. The system uses the imaging to create a model of the airways in the lungs while the tracking system uses fiber optic to provide the location and shape of the elongated medical device [0006, 0037]. The system then compares the position data to the airway model to determine whether the device is confined in the correct location or not (Confinement parameter) [0052-0053]. When the device’s position is determined to not correlate to a position within the model then the system determines which anatomical centerline is closest and corrects the model to display the corrected virtual location [0056].
In view of the Claim limitations Duindam uses the tracking system to determine where in the airway model the device is confined which broadly covers the limitation of “a confinent parameter expressing whether the elongated medical device will be confined at those position in the channel of interest”; as for the limitation of “mapping is limited to confined regions” the airway model covers the entirety of the bronchial passageway where the device is inserted which is inherently a confined region [0048].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure (US 20200046283 A1, US 20150141808 A1, DE 102018108643 A1, US20170265946A1).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN MALDONADO whose telephone number is 703-756-1421. The examiner can normally be reached 8:00 am-4:00 pm PST M-Th Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at
http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached on (571) 272-7230. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Steven Maldonado/
Patent Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797