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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Analysis step 1 of Subject Matter Eligibility Test
The claims are directed to a machine (i.e., a navigation system) of claims 1-16 and a process of claims 17-20.
Analysis step 2A, Prong I
The claims recite abstract ideas, in particular mental processes, e.g., concepts performed in the human mind merely applying mathematical concepts (including registering, detecting, determining).
Claims 1, 9, 17 recites “register data, detected by the catheter in the luminal network, to CT data of the luminal network; detect when the catheter is located at a node of the luminal network; determine coordinates of the detected node; determine a difference between the determined coordinates of the node and expected coordinates of the node; and determine whether the difference between the determined coordinates and the expected coordinates is greater than a predetermined threshold.” which encompasses mental observations or evaluations applying mathematical concepts, e.g., a skilled in the art under the broadest reasonable interpretation, can just register the data points, detect the catheter location in the images, determine the coordinates, determine the shift from the expected coordinate and determine the difference is greater than a predetermine threshold value.
Analysis step 2A, Prong II
The judicial exception is not integrated into a practical application because the additional elements merely add insignificant extra-solution activity and are mere instructions to implement an abstract idea on a computer. See MPEP 2106.05 (f) and (g).
Claims 1 recites “a navigation system comprising; a catheter to capture images” which is insignificant extra-solution activity, in particular mere data gathering. Claim 1 also recites “a computing device including a processor and memory to store instructions” which is insignificant extra-solution activity, in particular insignificant application. Claims 9, 16 recite analogous limitations.
Analysis step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the processor is an additional element that merely results in instructions to implement an abstract idea on a computer that is well-understood, routine, and conventional activity previously known to the industry. The remaining additional elements merely add insignificant extra-solution activity, in particular mere data gathering and insignificant application, to the judicial exception that are well-understood, routine, and conventional activities previously known to the industry.
The dependent claims include additional elements that only generally link the use of the judicial exception to a particular technological environment or field of use and/or recite insignificant extra-solution activity.
Claims 1-20 are therefore directed to a judicial exception without significantly more. The claims are not patent eligible.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muller et al. (WO 2022/035584, hereinafter Muller).
With respect to claims 1, 9, 17 Muller discloses navigation system and method comprising: a catheter configured to be navigated through a luminal network and to capture images during navigation (see para. 0025, 0026, “the elongate device 131 is part of a flexible catheter or other biomedical device that can be sized and shaped to receive a medical instrument and to facilitate delivery of the medical instrument to a distal portion 138 of the elongate device 131 for various purposes. For example, the medical instrument of the medical instrument system 604 can be used for medical procedures, such as for survey of anatomic passageways, surgery, biopsy, ablation, illumination, irrigation, and/or suction. The medical instrument can include positional sensors, rate sensors, image capture probes, biopsy instruments, laser ablation fibers, and/or other surgical, diagnostic, and/or therapeutic tools. Further details regarding the medical instrument system 604 are described in greater detail below in connection with FIGS. 6 and 7.In some example embodiments (discussed in greater detail below in connection with FIG. 7), the elongated device 131 can include an endoscope or other biomedical devices having one or more image capture devices 747 positioned at the distal portion 138 of the elongated device 131 (as in the example shown in FIG. 1) and/or at other locations along the elongated device 131. In these embodiments, the one or more image capture devices 747 can capture one or more real navigational images or video (e.g., a sequence of one or more real navigational image frames) of anatomic passageways and/or other real patient anatomy while the elongated device 131 is within the anatomic region 150 of the patient.”
; a computing device including a processor and memory storing instructions which, when executed by the processor, cause the computing device to: register data, detected by the catheter in the luminal network, to CT data of the luminal network; detect when the catheter is located at a node of the luminal network; (see para. 0031, “the elongate device 131 can be registered to the anatomic model based on the positional sensor data generated by the positional sensor system 608 (and/or to endoscopic image data generated by the one or more image capture devices 747, if applicable) to (i) map the tracked position, orientation, pose, shape, and/or movement of the medical instrument system 604 within the anatomic region 150 to a correct position in real-time within the anatomic model, and/or (ii) determine a virtual navigational image of virtual patient anatomy of the anatomic region 150 from a viewpoint of the medical instrument system 604 at a location within the anatomic model 150 corresponding to a location of the elongate device 131 within the patient.” determine coordinates of the detected node; determine a difference between the determined coordinates of the node and expected coordinates of the node; and determine whether the difference between the determined coordinates and the expected coordinates is greater than a predetermined threshold (see landmarks within the lungs, see branching point, see branch division, see para. 0042 “At process 308, the method 300 captures positional sensor data at various times as the medical instrument system (e.g., the elongated device 131 of the medical instrument system 604) is navigated (e.g., driven) along the planned path generated at the process 304 en route to the target(s). In some implementations, these various times correspond to times the medical instrument system is positioned at anatomic landmarks, has navigated a specified distance, is approaching the end of the planned path, is approaching the target(s), and/or to other specified events. For example, in various implementations of the process 308, the medical instrument system is navigated along the planned path generated at the process 304 en route to a target when it is determined that the medical instrument system is proximate a recognizable anatomical landmark. In some examples pertaining to the anatomic region being anatomic passageways, the specified landmark may include a branch division point in the anatomic passageways. In examples where the anatomic passageways are pulmonary airways of the lungs, as in the anatomic region 150 of FIG. 1, the specified landmark may include a carina. For example, in such implementations, the process 308 can include a verification technique where the operator of the medical instrument system checks to ensure the medical instrument system is being driven along the correct pathway in accordance with the planned path (en route to the target(s)). In some embodiments, the verification technique can include instructing the operator to drive the medical instrument system to nearest landmarks along the navigated path, such as carinas in the driven path, and obtain image(s) using the one or more image capture devices 747 to compare with expected carinas along the planned path based on the virtual navigational image(s) associated with the virtual map of the patient’s anatomy..”
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With respect to claims 2, 10 Muller further teaches wherein the computing device is configured to determine coordinates of the detected node based on data detected from the catheter (see para. 0026, 0031).
With respect to claims 3, 11 Muller further teaches wherein the computing device is configured to: perform image depth sensing to determine a distance between the catheter and the detected node; and determine coordinates of the detected node based on data detected from the catheter and the determined distance between the catheter and the detected node (see para. 0026, 0031, 0049).
With respect to claims 4,12 Muller further teaches wherein the computing device is configured to update registration of the location data to the CT data of the luminal network if it is determined that the difference between the determined coordinates and the expected coordinates is greater than the predetermined threshold (see para. 0022).
With respect to claims 5, 13 Muller further teaches wherein the computing device is configured to determine a node corresponding to a location of the catheter if it is determined that the difference between the determined coordinates and the expected coordinates is not greater than the predetermined threshold (see para. 0042).
With respect to claims 6, 14 Muller further teaches wherein the computing device is configured to detect when the catheter is at the node based on an image analysis of the images captured during navigation (see para. 0042).
With respect to claims 7, 15 Muller further teaches wherein the computing device is further configured to: estimate expected changes of the luminal network during navigation; and determine if changes of the luminal network during navigation differ from the estimated expected changes (see para. 0059, 0067).
With respect to claims 2, 10 Muller further teaches wherein the computing device is configured to: analyze a captured image of the node to calculate an angle and a distance between two lumens at the node; and determine translation and rotation differences between the catheter data and the CT data based on the calculated angle and distance between the two lumens at the node (see para. 0041).
With respect to claim 18 Muller further teaches further comprising updating registration of the data detected by the catheter to the CT data of the luminal network if it is determined that the difference between the determined coordinates and the expected coordinates is greater than the predetermined threshold (see para. 0022).
With respect to claim 19 Muller further teaches further comprising determining a node corresponding to a location of the catheter if it is determined that the difference between the determined coordinates and the expected coordinates is not greater than the predetermined threshold (see para. 0026, 0031).
With respect to claim 20 Muller further teaches comprising detecting when the catheter is at the node based on images captured during navigation (see para. 0026, 0031).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M SANTOS RODRIGUEZ whose telephone number is (571)270-7782. The examiner can normally be reached Monday-Friday 8:30am to 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M. Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797