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
Claims 1-20 remain pending, and claims 15-20 still withdrawn from consideration, in the application in response to the applicant’s amendments to the rejections previously set forth in the Non-Final Office Action mailed 04/08/2026.
Response to Arguments
Applicant’s arguments filed 07/08/2026 with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Given the amendments to claim 1, reference to Seely is being relied upon to teach dependent claims 2-3 and 8-9 more-consistently with the instant claim language, as shown below.
Given the amendments to claim 1, reference to Dalal is being relied upon to teach dependent claims 4-5 and 13-14 more-consistently with the instant claim language, as shown below.
Given the amendments to claim 1, reference to Khadem is being relied upon to teach dependent claim 12 more-consistently with the instant claim language, as shown below.
Given the amendments to claim 1, reference to Meyer is being relied upon to teach dependent claims 10-11 more-consistently with the instant claim language, as shown below.
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 1-5, 8-9, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Seeley et al. (US 20030088179 A1, published May 8, 2003) in view of Dalal et al. (US 20160228095 A1, published August 11, 2016) and Khadem et al. (US 20090259230 A1, published October 15, 2009), hereinafter referred to as Seeley, Dalal, and Khadem, respectively.
Regarding claim 1, Seeley teaches a method for performing percutaneous nephrolithotomy, the method comprising:
generating a first image of a treatment area of a patient using the fluoroscope; generating a second image of the treatment area of the patient using the fluoroscope (see para. 0020 – “The initial set of fluoroscopic images [first and second images] may, for example, be acquired by taking a series of views rotating the fluoroscope in a fixed plane about a target region of tissue.”);
selecting a first target location corresponding to a target treatment point on the first image; selecting a second target location corresponding to the target treatment point on the second image (see para. 0020 – “The initial set of fluoroscopic images [first and second images] may, for example, be acquired by taking a series of views rotating the fluoroscope in a fixed plane about a target region of tissue [selected target region in first and second images].”); and
calculating a three-dimensional position of the target treatment point based on the first target location selected on the first image and the second target location selected on the second image (see para. 0020 – “A common center and coordinate axes are determined for the reconstructed volume, such that the volume image data set constructed from the images corresponds to the target region [3D position of target location based on first and second images].”).
Seeley teaches an optical tracking system and a fluoroscope (Fig. 1; see para. 0036 – “As will be understood by those skilled in the art, fluoroscopes typically operate with an x-ray source 22 positioned opposite the camera or image sensing assembly 24.”; see para. 0022 – “The tracking elements of the tracking system may comprise various position-indicating elements or markers which operate optically…”; see para. 0046 – “…wherein a tracking system tracks the surgical instrument 40…”), but does not explicitly teach registering the optical tracking system and the fluoroscope to a global coordinate system.
Whereas, Dalal, in an analogous field of endeavor, teaches
registering an optical tracking system to a global coordinate system (see para. 0040 – “The spatial registration combines the imaging coordinate system (from, e.g., imaging data, selected critical structures, selected sensors, etc.) and tracking coordinate system (from, e.g., tracked medical device 134, tracked sensors 138, etc.) into the global coordinate system.”); and
registering a fluoroscope to the global coordinate system (see para. 0040 – “The spatial registration combines the imaging coordinate system (from, e.g., imaging data, selected critical structures, selected sensors, etc.) and tracking coordinate system (from, e.g., tracked medical device 134, tracked sensors 138, etc.) into the global coordinate system.”; see para. 0025 – “It should be understood that imaging system 124 is not limited to an ultrasound system, but rather may include any imaging system, particularly those suitable for real time imaging, such as, e.g., fluoroscopy, etc.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the optical system and fluoroscope, as disclosed in Seeley, by registering the optical system and fluoroscope to a global coordinate system, as disclosed in Dalal. One of ordinary skill in the art would have been motivated to make this modification in order to combine the images and real time spatially tracked data into a single global coordinate system, as taught in Dalal (see para. 0040).
Seeley in view of Dalal teaches generating images and a medical instrument, but does not explicitly teach overlaying a medical instrument proposed guidance line on an image.
Whereas, Khadem, in an analogous field of endeavor, teaches overlaying a medical instrument proposed guidance line on the first image, the second image or both the first image and the second image, wherein the medical instrument proposed guidance line depicts a proposed insertion pathway from an insertion point on the patient's body to the target treatment point (Fig. 3; see para. 0069 – “The entry regions 166a-166c can be any appropriate region identified relative to the target 164 that allows an instrument to move from the entry region 166a-166c [insertion point] to the target 164 [target treatment point].”; see para. 0072 – “The regions of trajectories 170a-170c [medical instrument proposed guidance line] can be illustrated on the image data or superimposed on the image data 150…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified generating images, as disclosed in Seeley in view of Dalal, by also overlaying a medical instrument proposed guidance line on an image, as disclosed in Khadem. One of ordinary skill in the art would have been motivated to make this modification in order to provide an efficient and fast conveyance of information to the user, as taught in Khadem (see para. 0053).
Furthermore, regarding claim 2, Seeley further teaches wherein the first image, the second image or both the first and the second image are two-dimensional (see para. 0036 – “The C-arm moves about a patient for producing two dimensional projection images of the patient from different angles.”).
Furthermore, regarding claim 3, Seeley further teaches wherein the first image, the second image or both the first and the second image are three-dimensional (see para. 0020 – “The processor applies a reconstruction operation or procedure, for example, back projection of the registered images to form a volume image data set, e.g., a three dimensional set of image density values of a tissue volume.”).
Furthermore, regarding claim 4, Dalal further teaches wherein the medical instrument includes an access needle (Fig. 1; see para. 0032 – “The device 134 preferably includes a medical device, such as, e.g., a needle…”).
Furthermore, regarding claim 5, Dalal further teaches registering the access needle to the global coordinate system (see para. 0032 – “The device 134 preferably includes a medical device, such as, e.g., a needle…”; see para. 0028 – “The display 126 shows a medical device 134 having a tip portion 202. The display 126 may be used for image guidance of an interventional procedure. A critical structure 204 is selected by a user in the imaging coordinate system. The coordinate information is sent to the computation engine 116, which converts the coordinate information into the global coordinate system…”).
Furthermore, regarding claim 8, Seeley further teaches wherein the first image is generated by the fluoroscope when the fluoroscope is positioned at a first angular orientation, and wherein the second image is generated by the fluoroscope when the fluoroscope is positioned at a second angular orientation different from the first angular orientation (Fig. 1A; see para. 0036 – “The C-arm moves about a patient for producing two dimensional projection images of the patient from different angles.”).
Furthermore, regarding claim 9, Seeley further teaches wherein the second angular orientation is offset from the first angular orientation by 25-35 degrees (Fig. 1A; see para. 0036 – “The C-arm moves about a patient for producing two dimensional projection images of the patient from different angles [includes 25-35 degrees].”).
Furthermore, regarding claim 13, Dalal further teaches wherein a physician manually selects the first target location and the second target location (see para. 0026 – “For example, the interface 128 may allow a user to select areas or points of interest [target locations] on the images as user input 112.”).
Furthermore, regarding claim 14, Dalal further teaches wherein a computer selects the first target location and the second target location (see para. 0044 – “The measurement data may be displayed according to a selection of a sensor by the user or automatically depending on which sensors are relevant [target locations in images].”).
The motivation for claims 4-5 and 13-14 was shown previously in claim 1.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Seeley in view of Dalal and Khadem, as applied to claim 1 above, and in further view of L. Rai et al, "Fluoroscopic Image-Guided Intervention System for Transbronchial Localization", Proc. SPIE 8316, Medical Imaging 2012: Image-Guided Procedures, Robotic Interventions, and Modeling, vol. 8316 pp. 1-11, Feb. 2012, hereinafter referred to as Rai.
Regarding claim 6, Seeley in view of Dalal and Khadem teaches all of the elements disclosed in claim 1 above.
Seeley in view of Dalal and Khadem teaches overlaying a medical instrument proposed guidance line on an image, but does not explicitly teach overlaying a medical instrument alignment line on the image.
Whereas, Rai, in an analogous field of endeavor, teaches overlaying a medical instrument alignment line on the first image, the second image or both the first image and the second image, wherein the medical instrument alignment line depicts an alignment of the medical instrument relative to the treatment area (see Fig. 4 "The bronchoscopist has navigated through the airways to the planned point of entry. From this location, the bronchus was punctured and a catheter with radiopaque bands (inside parallel black lines marked by yellow arrow) was inserted into the parenchyma and advanced toward the overlaid target lesion (blue). The previously-identified safe path from the entry location to the lesion is highlighted by the tunnel guidance lines (parallel black lines).").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified overlaying a medical instrument proposed guidance line on an image, as disclosed in Seeley in view of Dalal and Khadem, by also overlaying a medical instrument alignment line on the image, as disclosed in Rai. One of ordinary skill in the art would have been motivated to make this modification in order to confirm proper trajectory in three dimensions, as taught in Rai (see Fig. 4).
Furthermore, regarding claim 7, Rai further teaches manipulating the medical instrument to align the medical instrument proposed guidance line with the medical instrument alignment line (see Fig. 4 "During guidance, the physician adjusts the bronchoscope to keep the accessory device between the guidance lines.").
The motivation for claim 7 was shown previously in claim 6.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Seely in view of Dalal and Khadem, as applied to claim 1 above, and in further view of Meyer et al. (US 20140228678 A1, published August 14, 2014), hereinafter referred to as Meyer.
Regarding claim 10, Seely in view of Dalal and Khadem teaches all of the elements disclosed in claim 1 above.
Seely in view of Dalal and Khadem teaches registering an optical tracking system to a global coordinate system and registering a fluoroscope to the global coordinate system, but does not explicitly teach simultaneously acquiring images and the positions of a fiducial marker.
Whereas, Meyer, in an analogous field of endeavor, teaches wherein registering an optical tracking system to a global coordinate system and registering a fluoroscope to the global coordinate system further includes simultaneously using the fluoroscope to generate the first image and the second image while the tracking system acquires the positions of a fiducial marker included in the first image and the second image (see para. 0040 – “The recorded 3D point pairs, the intersecting 2D fluoroscopic backprojections, and the simultaneously recorded tracking positions for the trackable marker may be used as a basis for a point based image to world coordinate system registration, calibration, or transformation.”; see para. 0025 – “…tracking markers (e.g., tracking coils, RFID chips, or center-of-mass representing fiducials). One or more of the tracking markers are visible in X-ray projections.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified registering an optical tracking system to a global coordinate system and registering a fluoroscope to the global coordinate system, as disclosed in Seely in view of Dalal and Khadem, by also simultaneously acquiring images and the positions of a fiducial marker, as disclosed in Meyer. One of ordinary skill in the art would have been motivated to make this modification in order to move a trackable device within the body without any additional live imaging after registration, as taught in Meyer (see para. 0091).
Furthermore, regarding claim 11, Meyer further teaches utilizing a transformation matrix to register a coordinate system of the fluoroscope with a coordinate system of the tracking system within the global coordinate system (see para. 0040 – “The recorded 3D point pairs, the intersecting 2D fluoroscopic backprojections, and the simultaneously recorded tracking positions for the trackable marker may be used as a basis for a point based image to world coordinate system registration, calibration, or transformation.”).
Furthermore, regarding claim 12, Khadem further teaches wherein first image, the second image or both the first image and the second image further includes a guidance line confidence indicator, and wherein the guidance line confidence indicator conveys a relative confidence level in the accuracy of the medical instrument proposed guidance line (see Abstract – “The system can use various weighting or determining factors to identify confidence of identified trajectories.”; see para. 0028 – “The processor system 26 can also include a confidence system or cost function processor 36, in a second work station 38.”).
The motivation for claims 11 and 12 was shown previously in claims 1 and 10.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Woei et al. (US 20240070933 A1, published February 29, 2024 with a priority date of August 22, 2022) discloses the physician marks the target in a second fluoroscopy view, preferably, at least 30-60 degrees from the first image view angle of the fluoroscope.
Amiri (US 20190320995 A1, published October 24, 2019) discloses the locations of the fiducial features in space (in a coordinate system of the X-ray machine) may be determined from the marked locations of the fiducial features in each image using the known spatial relationships of the images.
Mistretta et al. (US 20190076103 A1, published March 14, 2019) discloses a processor can overlay (or superimpose) a representation (or an image) of the interventional device on a previously acquired full dose CT 2D or 3D image of the target according to the determined position of the interventional device in the 3D volume space.
Ayvali et al. (US 20210298590 A1, published September 30, 2021) discloses the camera calibration may be relied upon to overlay/present a needle-trajectory icon/feature on a camera view window, wherein such icon/feature indicates expected/projected position in the field of view at/through which the percutaneous needle is expected to project/appear as the needle is approximated to the target.
Alvarez et al. (US 20150335480 A1, published November 26, 2015) discloses a coordinate system processing unit configured to generate a global coordinate system using optical coherence tomographic data generated by the first optical coherence tomographical imaging system and the second optical coherence tomographical imaging system, and kinematic registration databased on the location of the first mechanical arm, second mechanical arm, and the tool.
Simon et al. (US 20110268248 A1, published November 3, 2011) discloses visualizing where the instrument would be in the patient if it were advanced a predetermined distance in the patient.
Crawford et al. (US 20240074819 A1, published March 7, 2024 with a priority date of June 21, 2012) discloses the graphical representation may be three dimensional CT or a fluoroscope scan of the targeted anatomical structure of the patient which includes registration fixture and a detectable imaging pattern of fiducials.
Vilsmeier et al. (US 6527443 B1, published March 4, 2003) discloses x-ray images are made in various positions of the C-arm, and the x-ray image data (including the marker pattern defining the position and three-dimensional location) are referenced and assigned by means of the reflector adapter on the reference structure in the camera-assisted navigation system.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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/N.C./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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