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 .
DETAILED ACTION
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.
Claims 1-7, 10-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Koyrakh et al. (US 2018/0055576 (provided in the IDS)) and in view of Boctor et al. (US 2015/0031990).
Addressing claims 11 and 17, Koyrakh discloses an endoluminal navigation system comprising:
an electromagnetic (EM) field generator configured to generate an electromagnetic field (see [0035]; 145);
a first EM sensor disposed at a tip of the medical tool (see [0036]; 115);
one or more second EM sensors disposed on a patient (see [0031] and Fig. 1; 170);
a processor; and a memory having stored thereon instructions, which, when executed by the processor, cause the processor to: receive preoperative 3D images (see abstract; pre-procedure 3D model);
track navigation of the medical tool towards a target using the first EM sensor (see [0045]);
intraoperatively track motion of the patient using the one or more second EM
sensors disposed on the patient, yielding tracked patient motion (see [0047]);
an electromagnetic (EM) field generator configured to generate an electromagnetic field (see [0035]; 145);
a first EM sensor disposed at a tip of a medical tool (see [0036]; 115);
one or more second EM sensors disposed on a chest of a patient (see [0031-0033]; 118);
a display (see Fig. 1 and [0031]; 130);
a processor; and a memory having stored thereon instructions, which, when executed by the processor, cause the processor to: receive preoperative 3D images (see abstract; pre-procedure 3D model);
track navigation of the medical tool towards a target using the first EM sensor (see [0045]);
intraoperatively track motion of the patient using the one or more second EM
sensors disposed on the chest of the patient, yielding tracked patient motion (see [0047]);
Koyrakh does not disclose a robotic arm configured to hold and navigate a medical tool; receive preoperative 3D images of motion of the patient; determine 3D motion of the target in the patient based on the preoperative 3D images and the tracked patient motion; control the medical tool to align with the target during motion of the patient using the first EM sensor and the 3D motion of the target. In the same field of endeavor, Boctor discloses a robotic arm configured to hold and navigate a medical tool (see [0032], [0049], [0051] and [0189]); receive preoperative 3D images of motion of the patient (see [0006], [0015], [0034], [0048], [0056], [0067-0068] and [0200]; preoperative images/model; since there are plurality of preoperative images/models and the images are not taken at a time point and there is patient motion/breathing therefore the images/models are images of motion of the patient); determine 3D motion of the target in the patient based on the preoperative 3D images and the tracked patient motion (see [0034] and Fig. 1; images have been registered with preoperative CT and used to create a real time video overlay display of the tumor within the kidney, which was tracked using a small EM sensor implanted into the tumor, thus providing continuing feedback on intact tumor location and resection margins during resection which is insert, track and align tool inside the body with the target; this is determine 3D motion of the target in the patient based on the preoperative 3D images and the tracked patient motion; register with preoperative 3D images to display images/video of motion of the target; the motion also determine from tracking EM sensor implanted to the target/tumor) control the medical tool to align with the target during motion of the patient using the first EM sensor and the 3D motion of the target (see Figs. 1, 8, [0015], [0034], [0069]; preoperative register with real-time image, track tool and target tumor with embedded/implant EM sensors allow physician to have real-time view of target tumor and align tool to treat target). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Koyrakh to determine 3D motion of the target in the patient based on the preoperative 3D images and the tracked patient motion as taught by Boctor because this improve calibration errors, accuracy and provide continuous feedback of tool and target site (see [0033-0034]).
Addressing claims 12, 14 and 16, Koyrakh discloses:
addressing claim 12, wherein the preoperative 3D images
are captured during at least one respiratory cycle of the patient (see abstract and [0026]; take images at one point in respiration cycle; that is images capture during at least one respiratory cycle of the patient).
addressing claim 14, wherein the one or more second EM sensors are disposed on a chest of the patient and configured to track the motion of the chest of the patient during at least one respiratory cycle (see Fig. 1, [0031] and [0038]; 170 on patient chest is being track during medical procedure as the patient breathes).
addressing claim 16, wherein the medical tool is an extended working channel or a biopsy tool (see [0024]).
Addressing claims 13, 15 and 20, Boctor discloses:
addressing claim 13, wherein the instructions, when executed by the processor, further cause the processor to control the robotic arm to navigate the medical tool towards the target during patient motion (see [0032], [0049], [0051] and [0189]).
addressing claim 15, wherein the instructions, when executed by the processor, further cause the processor to control the robotic arm to navigate the medical tool through a luminal network of the patient (see [0032], [0049], [0051] and [0189]; Koyrakh discloses luminal network (see [0031-0032] and [0036])).
addressing claim 20, wherein the instructions, when executed by the processor, further cause the processor to register the preoperative 3D images to the 3D motion of the target (see [0015] and [0032]; register preoperative CT images/model with intraoperative ultrasound images).
Addressing claims 1-7 and 10, the methods of claims 1-7 and 10 are being performed by the systems in claims 11-17 and 20 therefore claims 1-7 and 10 are being rejected for the same reason as claims 11-17 and 20. The references do not disclose FRI; however, using any imaging techniques (CT, MRI or FRI) only require routine skill in the art and it is designer choice. The references disclose CT and MRI. Applicant’s invention discloses any imaging techniques could be use. Applicant’s invention discloses imaging techniques used are CT, MRI, FRI. Boctor discloses images have been registered with preoperative CT and used to create a real time video overlay display of the tumor within the kidney, which was tracked using a small EM sensor implanted into the tumor is preoperative CT images register with tracked patient motion.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Koyrakh et al. (US 2018/0055576 (provided in the IDS)), in view of Boctor et al. (US 2015/0031990) and further in view of Razzaque et al. (US 2017/0128139).
Addressing claims 8 and 18, Koyrakh does not disclose wherein the instructions, when executed by the processor, further cause the processor to display an indicator of at least one direction in which to navigate the medical tool to reach the target. Razzaque discloses wherein the instructions, when executed by the processor, further cause the processor to display an indicator of at least one direction in which to navigate the medical tool to reach the target (see [0074], Figs. 3A-B and 6-7; the virtual rings is an indicator). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Koyrakh to have wherein the instructions, when executed by the processor, further cause the processor to display an indicator of at least one direction in which to navigate the medical tool to reach the target as taught by Razzaque because this may allow the physician to verify that the needle is properly aimed at the target and can drive the needle forward into the tissue such that it reaches its desired target or destination (see [0074]).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Koyrakh et al. (US 2018/0055576 (provided in the IDS)), in view of Boctor et al. (US 2015/0031990) and further in view of Wei et al. (US 2015/0208948).
Addressing claims 9 and 19, Boctor discloses segment images to determine target, target’s location/position, etc.; however, Boctor does not disclose the segmented images are preoperative images. Segmenting any images is a designer choice that only requires routine skill in the art. Wei explicitly discloses segmenting preoperative images to get the target’s location/position (see [0026] and Fig. 1; the target lesion is segmented from the preoperative images and displayed as 3D lesion objects). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Koyrakh to segment the target from the preoperative 3D images as taught by Wei because this help clearly display the target object in the image on the display (see [0026]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2021/0085268 (see [0070]; projection indicator to guide needle to follow the planned trajectory to the target) and US 2012/0253200 (see Fig. 13, [0160]; EM sensor to track tumor target in the image created from register preoperative 3D CT images with real-time ultrasound; this is determine 3D motion of the target in the patient base on preoperative 3D images and the tracked patient motion).
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
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