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 Arguments
In the remarks filed 13 April 2026 on Pages 11-12, the arguments regarding Brattain not qualifying as prior art and the teachings of Bagwell are convincing. The references are herein removed and a new final rejection is set forth below.
The rejection of Claim 39 under 35 U.S.C. 112(d) is withdrawn in view of cancelation of the claim.
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) 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takagi (US 20160008082).
Regarding Claim 35, Takagi teaches a method, (Claim 16 “puncture planning method”), of controlling a robotically controlled system in an interventional procedure of a subject, the method including causing a processor to carry out steps comprising ([0064] “This puncture system is a system for performing puncture (needle insertion) into an organ 21 of a human 20, and is mainly constituted by a puncture robot 11, an image acquiring apparatus 12, a puncture control apparatus 13 and a display apparatus 14.”):
a) access image data acquired from the subject using an ultrasound probe, ([0066] “The image acquiring apparatus 12 is an apparatus to acquire a tomographic image and/or a three-dimensional image of the organ 21. For the image acquiring apparatus 12, an ultrasound diagnostic apparatus […] can be used.”), wherein the image data include at least one image of a target structure of the subject, ([0067] “target segment 22”), and at least one critical structure, ([0064] “organ 21”), within the subject ([0066] “The image data acquired by the image acquiring apparatus 12 is used for generating an organ model used for the later mentioned puncture simulation, and outputting image guidance when puncture is actually performed”);
b) determine, from the image data, a location of the target structure within the subject and the at least one critical structure ([0066] “The image data acquired by the image acquiring apparatus 12 is used for generating an organ model used for the later mentioned puncture simulation” and [0113] “the puncture simulation unit 130 determines the initial target angle θ.sub.t0 based on the positional relationship of the insertion point and the target (step S100)”);
c) determine a safe pathway for the interventional device to reach the target structure without impinging on the at least one critical structure based upon the location of the target structure and the at least one critical structure ([0076] “It is also preferable that the simulation result, in which both the puncture error when the puncture is generated and the maximum value of the puncture error after the puncture needle contacts the organ are within tolerance, is selected as the best simulation result. This is because the time required for puncture can be decreased, and the risk of damaging healthy tissue can be lessened by not only minimizing ultimate puncture error, but also minimizing error in the middle of insertion” and [0084] “in order to reach the puncture target segment without error, and planning is performed so that the angle θ of the puncture needle 1 properly adjusted as the puncture needle advances” and Claim 16 “a planning step of the computer planning, based on a result of the simulation, how to move a puncture needle when an actual organ is punctured, and outputting a planning result”);
d) guide the interventional device, along the safe pathway, from an insertion point to the target structure (Fig. 3 and [0079] “it is preferable that the manipulator is controlled such that the puncture needle 1 always passes through the insertion point 3 (xh, yh) on the body surface 4”); and
e) reduce an insertion speed of the interventional device as the interventional device approaches the target structure along the safe pathway (Fig. 6C and [0086] “the needle advancement speed can be continuously reduced as the puncture reaction force increases.”).
Regarding Claim 36, Takagi teaches all limitations of Claim 35, as discussed above. Furthermore, Takagi teaches wherein the processor is further caused to determine an insertion angle for the interventional device using at least one of an insertion point location, the location of the target structure, or the location of the at least one critical structure ([0113] “the puncture simulation unit 130 determines the initial target angle θ.sub.t0 based on the positional relationship of the insertion point and the target (step S100)”).
Regarding Claim 40, Takagi teaches all limitations of Claim 35, as discussed above. Furthermore, Takagi teaches wherein the target structure is one of an artery, a vein, a femoral artery, a femoral vein, a jugular vein, a peripheral vein, a subclavian vein, an airway, a lumen, a luminal organ, a body cavity, a fluid filled anatomic space, ([0065] “The puncture needle 110 may include, depending on the intended use, […] a unit that collects body fluid”), a location requiring biopsy, ([0065] “The puncture needle 110 may include, depending on the intended use, […] a unit that collects […] tissue”), a breast, a kidney, a lymph node, a spinal canal, a location requiring nerve block, a peritoneal space or a pleural space.
Regarding Claim 45, Takagi teaches all limitations of Claim 35, as discussed above. Furthermore, Takagi teaches wherein the interventional device is one of a needle, ([0065] “puncture needle 110”), wire, dilator, breathing tube, chest tube, vascular catheter, blood clotting agent, a drainage catheter, an injectable delivery carrier, a hydrogel, or drug, or is configured to provide at least one of vascular access, access to an organ or body cavity, perform cricothyrotomy, take a tissue sample, ([0065] “The puncture needle 110 may include, depending on the intended use, […] a unit that collects body fluid, tissue”), alleviate pneumothorax, drain fluid from a body cavity, ([0065] “The puncture needle 110 may include, depending on the intended use, […] a unit that collects body fluid”), drain pus from an abscess, or drain cerebrospinal fluid from a spinal canal.
Regarding Claim 46, Takagi teaches all limitations of Claim 35, as discussed above. Furthermore, Takagi teaches wherein the insertion speed is reduced based on an increase in a friction force as the interventional device is injected deeper in the subject after a first decrease in the friction force (Figs. 6A,C,D and [0086] “needle advancement speed can be continuously reduced as the puncture reaction force increases.”).
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 37-38 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Takagi (US 20160008082) in view of Kumar et al. (US 20130116548).
Regarding Claim 37, Takagi teaches all limitations of Claim 36, as discussed above. However, the Takagi does not explicitly teach wherein the processor is further caused to determine a distance to a distal wall of the target structure from the insertion point.
In an analogous prostate biopsy field of endeavor, Kumar teaches a method of controlling a robotically controlled system, ([0040] “The probe handle is held by a robotic arm”), to determine a safe pathway for guiding an interventional device in an interventional procedure of a subject, (Abstract “The invention presents tools to improve a 3-D image aided biopsy or treatment procedure for prostate gland by providing additional functionality and additional visual cues on an output image of the prostate, which may be generated substantially in real-time.”), wherein the processor, ([0040] “computer 20”), is further caused to determine a distance to a distal wall of the target structure from the insertion point ([0022] “The system displays a ruler representing the distance from the prostate surface at the further end from the needle entry point along the needle trajectory.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Takagi with the teachings of Kumar by determining a distance to a distal wall of the target structure from the insertion point because the modification ensure that the user knows how deep the inserted needle is relative to the prostate boundaries (which include the distal wall of the target structure), as taught by Kumar in [0022], so as to accurately carry out the biopsy, or other insertable treatment.
Regarding Claim 38, the modified method of Takagi teaches all limitations of Claim 36, as discussed above. Furthermore, Kumar teaches wherein the processor is further caused to determine an overshoot estimation based upon the determined insertion angle and the determined distance to the distal wall of the target structure ([0063] “The ruler shows the distance from the prostate boundary along the needle guide line 120” and Figs. 11 and 12, which demonstrate the insertion angle).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Takagi with the teachings of Kumar by determining an overshoot estimation because puncturing through the target structure can have harmful implications on the patient.
Regarding Claim 45, the modified method of Bagwell teaches all limitations of Claim 35, as discussed above. Furthermore, Kumar teaches wherein the processor is further caused to determine an overshoot estimation, ([0063] “The ruler shows the distance from the prostate boundary along the needle guide line 120”), and guide the interventional device to penetrate the target structure without penetrating a distal wall of the target structure based upon the overshoot estimation (Fig. 11 and [0063] “The ruler shows the distance from the prostate boundary along the needle guide line 120. For a given needle guide line 120, as the user inserts the needle along the needle guide line 120, the system computes the needle trajectory in 3-D, finds intersection of the trajectory with the pre-computed prostate boundaries in 3-D and converts the intersection point back to frame of reference of the 2-D image. The distance can be shown in cm (or mm) from the point of intersection of the needle with the segmented surface. The system then drops down a ruler 120 from this point of intersection to give the user the distance measurement from the distal end of prostate such that the user can always see how far the needle tip is from the prostate boundaries and can thus avoid overshooting.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the teachings of Kumar by determining an overshoot estimation and guiding the interventional device because puncturing through the distal wall of the target structure can have harmful implications on the patient.
Claims 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Takagi (US 20160008082) in view of Von Allmen et al. (US 20170188990).
Regarding Claim 41, Takagi teaches all limitations of Claim 35, as discussed above. However, Takagi does not explicitly teach wherein the image data includes a plurality of views of the target structure, and wherein the processor is configured to assess the plurality of views to identify a critical structure in the subject and identify a location on the subject where the interventional device reaches the target structure from an insertion point location without penetrating the critical structure in the subject.
In an analogous image guided needle insertion field of endeavor, Von Allmen teaches a method of controlling a robotically controlled system in an interventional procedure of a subject, ([0002] “The present invention relates to surgical robots and, more particularly, to a […] method of using ultrasound in percutaneous medical procedures, such as needle insertion into a subcutaneous vein.”), wherein the image data includes a plurality of views of the target structure, (Figs. 25-34), and wherein the processor is configured to assess the plurality of views to identify a critical structure in the subject, ([0057] “The high level processor 18 illustratively includes an image processor 34 and a path planner 36. The image processor 34 analyzes the information provided by the ultrasound system 12 (e.g., ultrasound images 33), detects regions of interest (ROI), and tracks movements of the needle assembly 30” and [0115] “Image segmentation is primarily used to identify the boundaries and objects in given US images”), and identify a location on the subject where the interventional device reaches the target structure from an insertion point location without penetrating the critical structure in the subject ([0081] “The path planner 36 computes high-level actions that will have the highest probability of avoiding obstacles while guiding the needle 78 to the target vein 60. For a given needle-tissue combination and a set of anatomical structures, there may be multiple feasible paths that the needle 78 could take to reach a target vein 60 while avoiding obstacles. The shortest path to the target vein 60 will ensure that most of the needle 78 is located inside the tissue.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Takagi with the teachings of Von Allmen because the modification minimizes risk of damage to healthy tissue within the patient.
Regarding Claim 42, the modified method of Takagi teaches all limitations of Claim 41, as discussed above. Furthermore, Takagi teaches wherein the critical structure includes at least one of a bone, an unintended blood vessel, ([0073] “a model of an organ (liver in this embodiment)” and [0101] “path correction after the needle enters the organ can be minimized, which reduces the risk of damage the healthy tissue inside the organ.”), a non-target organ, or a nerve.
Claims 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Takagi (US 20160008082) in view of Bagwell et al. (US 20200261113).
Regarding Claim 43, Takagi teaches all limitations of Claim 35, as discussed above. However, Takagi does not explicitly teach wherein the processor is further caused to determine a blood flashback.
In an analogous insertion of a penetrating member field of endeavor, Bagwell teaches a method of controlling a robotically controlled system, ([0040] “The probe handle is held by a robotic arm”), in an interventional procedure of a subject, (Abstract “The invention presents tools to improve a 3-D image aided biopsy or treatment procedure for prostate gland by providing additional functionality and additional visual cues on an output image of the prostate, which may be generated in real-time.”), wherein the processor is further caused to determine a blood flashback ([0099] “the appearance of fluid, such as blood, in the penetrating member, also referred to as “flashback,” may be detected through mechanisms such as […] change in resistance to a sub-circuit, or change in resonance frequency or phase of the vibrating needle tip, to name but a few. Other methods of confirming the tip of the penetrating member 10 has reached the preselected target point 29 may also be used.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Takagi with the teachings of Bagwell by determining blood flashback because this confirms that the interventional device has been inserted to the needle, and the procedure may be further completed (e.g., blood draw or drug delivery).
Regarding Claim 44, the modified method of Takagi teaches all limitations of Claim 35, as discussed above. Furthermore, Bagwell teaches wherein the processor is further caused to advance the interventional device toward the critical structure in the absence of blood flashback ([0134] “Achieving the target site may be confirmed by the presence of an appropriate volume of blood or fluid escaping from the target, indicating the distal tip of the penetrating member 310 is located within the interior volume of a blood vessel” and [0135] “Upon confirmation of successful introduction of the penetrating member 310 to the intended target, such as by the appearance of blood or other bodily fluid appropriate for the tissue penetrated, the interior of the target site may be access for extracting or inserting materials through the penetrating member 310. For instance, blood may be collected, drugs or solutions may be applied, and/or a flexible guide wire may be inserted through hollow interior of the penetrating member 310,” where penetrating member 310 (interventional device) will continue to advance util blood escapes.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Takagi with the teachings of Bagwell by advancing the interventional device toward the critical structure in the absence of blood flashback for the same reasons as Claim 43 above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA CHRISTINA TALTY/ Examiner, Art Unit 3797
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
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