CTFR 18/499,179 CTFR 96917 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 Applicant’s amendment filed 4/1/2026 is acknowledged. Claims 1, 2, 5, 6, 11-15 and 17 remain pending in the current application. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 1, 2, 5, 6, 11-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire (US 20150065916 A1) in view of Roh (US 11464573 B1) . Regarding claim 1, Maguire teaches a method for remote intervention of a subject ([0059] robotic effector comprising a needle, a needle attachment unit, and a needle actuation system that positions the needle at the selected vessel target located by the image processing software, and a computer connected to the imaging system and robotic effector, said computer directing, continuously and in real-time, information to and from the imaging system, image processing software, and robotic end-effector in order to autonomously adjust the position and orientation of the needle with respect to the selected vessel target during the cannulation routine) the method comprising acquiring an image of a region of interest of the subject using an interventional device positioned on the subject and an image acquisition system, the region of interest including a target structure and the subject is located at a first site ([0020] imaging system for providing continuous and real-time imaging of blood vessels; said imaging system comprising at least one of optical, acoustic, photoacoustic, or tactile imaging; image processing software for generating a continuous and real-time three-dimensional (3D) computer model of the blood vessels based on the imaging system, and selecting an optimal vessel target based on visual and anatomical information for inserting a needle into the selected vessel target during a cannulation routine on a human subject) analyzing the acquired image using an image analysis module to identify and label the target structure in the region of interest ([0020] imaging system for providing continuous and real-time imaging of blood vessels, said imaging system comprising at least one of optical, acoustic, photoacoustic, or tactile imaging; image processing software for generating a continuous and real-time three-dimensional (3D) computer model of the blood vessels based on the imaging system; [0024] The image processing software preferably processes and maps a three-dimensional (3D) computer model of blood vessels continuously and in real-time) and receiving a command signal at the first site, the command signal generated and configured to enable a deployment function of the interventional device ([0020] a needle actuation system that positions the needle at the selected vessel target located by the image processing software and moves the needle toward and insert the needle into the selected vessel target). Maguire fails to teach a supervised intervention and transmitting the labelled image from the first site to a second site for expert review and verification, wherein the second site is remote from the first site. However, Roh teaches a supervised intervention and transmitting the labelled image from the first site to a second site wherein the second site is remote from the first site ((col. 24 line 65 – col 25 line 3) information can include, without limitation, surgical or implantation plans, patient vitals, modification to surgical plans, values, scores, predictions, simulations, and other output, data, and information disclosed herein. The console 420 can be located at the surgical room or at a remote location) for expert review and verification and generating a command signal based on the expert review ((col. 26 lines 58-64) The user and surgical team can review the proposed surgical plans to select an appropriate surgical plan. The robotic surgical system 400 can modify a surgical plan with one or more corrective surgical steps based on identified surgical complications (col. 27 line 67 – col. 28 line 3) The physician can review the virtual simulations to accept or reject the recommended surgical plan. The physician can modify surgical plans pre-operative or intraoperatively; (col. 4 lines 47-59) The vital signs monitor can be used with an isolated data link to an interconnected portable computer or the console 108, allowing snapshot and trended data from the vital signs monitor to be printed automatically at the console 108, and also allowing default configuration settings to be downloaded to the vital signs monitor. The vital signs monitor is capable of use as a stand-alone unit as well as part of a bi-directional wireless communications network that includes at least one remote monitoring station (e.g., the console 108). The vital signs monitor can measure multiple physiological parameters of a patient wherein various sensor output signals are transmitted either wirelessly or by means of a wired connection to at least one remote site, such as the console 108) Maguire and Roh are considered analogous because both disclose medical monitorization systems. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to transfer acquired images to a remote console for analysis and physician verification in order to prevent surgical errors and adverse events during surgery (Roh (col. 1 line 35)). Regarding claim 2, Maguire fails to teach analyzing the acquired image to detect critical structures that a needle should avoid and computing a pathway from a surface of the subject such that the needle avoids the critical structures and intersects with the target structure ((col. 28 lines 4-13) mapping the surgical path for neurosurgery procedures that minimize damage through artificial intelligence mapping. The software for artificial intelligence is trained to track the least destructive pathway. A surgical robot can make an initial incision based on a laser marking on the skin that illuminates the optimal site. Next, a robot can make a small hole and insert surgical equipment (e.g., guide wires, cannulas, etc.) that highlights the best pathway. This pathway minimizes the amount of tissue damage that occurs during surgery) Maguire and Roh are considered analogous because both disclose medical monitorization systems. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to plan a surgical route that is mindful of vital interventional structures in order to prevent surgical errors and adverse events during surgery (Roh (col. 1 line 35)). Regarding claim 5, Maguire teaches after enablement of the deployment function receiving a user input to the interventional device at the first site configured to cause the deployment of a needle of the interventional device based on the command signal ([0020] a needle actuation system that positions the needle at the selected vessel target located by the image processing software and moves the needle toward and insert the needle into the selected vessel target; [0030] input settings and parameters can be controlled manually prior to or during the cannulation routine in order to direct the cannulation routine; [0113] Using predetermined weight parameters as inputs to the final decision system, identify and rank potential cannulation sites based on their measured suitability for puncture. Herein, by limiting the set of possible positions for needle insertion to these targets, the likelihood of diversion error during the vessel tracking phase is reduced). Maguire and Roh are considered analogous because both disclose medical monitorization systems. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to transfer acquired images to allow a physician to manually verify the functionality of the device in order to prevent surgical errors and adverse events during surgery (Roh (col. 1 line 35)). Regarding claim 6, Maguire fails to teach the image analysis module is implemented as a machine learning network. However, Roh teaches the image analysis module is implemented as a machine learning network ((col. 1 line 42) FIG. 2 is a block diagram illustrating an example machine learning (ML) system, in accordance with one or more embodiments). Maguire and Roh are considered analogous because both disclose medical monitorization systems. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to plan a surgical route that is mindful of vital interventional structures in order to prevent surgical errors and adverse events during surgery (Roh (col. 1 line 35)). Regarding claim 11, Maguire fails to teach wherein transmitting the labelled image from the first site to a second site for expert review comprises transmitting the labelled image from the first site to the second site over a communication network. However, Roh teaches wherein transmitting the labelled image from the first site to a second site for expert review comprises transmitting the labelled image from the first site to the second site over a communication network ((col. 20 lines 18-20) the console 108, the equipment in the doctor's office 110, and the EHR database 106 are communicatively coupled to the equipment in the operating room 102 by a direct connection, such as ethernet, or wirelessly by the cloud over the network 104) Maguire and Roh are considered analogous because both disclose medical monitorization systems. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to connect the consoles of the system through a computerized network in order to prevent surgical errors and adverse events during surgery (Roh (col. 1 line 35)). Regarding claim 12, Maguire teaches the interventional device is a remote vascular access device ([0010] fully automated vascular imaging and access) the target structure is a target vessel ([0076] target vein) and analyzing the acquired image using an image analysis module to identify and label a target structure in the region of interest comprises determining one or more of a location of the target vessel, a centroid depth of the target vessel, and a diameter of the target vessel ([0025] The detected veins are preferably automatically labeled and the selected vessel target is automatically determined based on at least one of the size and anatomical structure of the blood vessels, the quality of the image at each location, the particular needle and application, and the subject's medical information). Regarding claim 13, Maguire teaches determining if the target vessel is appropriate for needle insertion based on the determined diameter of the target vessel ([0025] The detected veins are preferably automatically labeled and the selected vessel target is automatically determined based on at least one of the size and anatomical structure of the blood vessels, the quality of the image at each location, the particular needle and application, and the subject's medical information). Regarding claim 14, Maguire teaches the interventional device is configured to be positioned around an arm of the subject ([0037] The imaging system and end-effector unit can additionally be contained in a single unit. This unit will be capable of either being mounted onto a target limb (classically the forearm for venipuncture). Regarding claim 15, Maguire teaches the interventional device comprises a cuff configured to be positioned around an arm of the subject ([0040] an air-inflatable cuff-like structure enclosed around the appendage). Regarding claim 17, Maguire teaches monitoring the interventional device based on images acquired using the interventional device and the image acquisition system to determine a change in position of the interventional device ([0024] tracking the position and orientation of a the selected vessel target and the needle tip as the needle is moved toward and inserted into the selected vessel target; relaying information about the position and orientation of the selected vessel target and the needle based on the vessel and needle tip positions as the needle is moved toward and inserted into the selected vessel target) and disabling the deployment function of the interventional device based on a determined change in position of the interventional device ([0121] A safety-release mechanism is also incorporated that allows the needle to be released manually when the vein target is reached actuation is no longer needed, or in cases of emergency where the needle must be immediately detached) Response to Arguments 07-37 AIA Applicant's arguments filed 4/1/2026 have been fully considered but they are not persuasive. Applicant alleges that due to Maguire being a fully automated and self-contained system, Maguire cannot teach the limitations regarding expert review and verification. While this is true, this is the express purpose for which the secondary Roh reference was brought in. Applicant further argues that these limitations are not found in Roh due to Roh being a system for real-time control of a surgery system. However, there are multiple excerpts from Roh which teach a remote location for expert review including the newly cited excerpt from col 27 line 67 – col 28 line 3 reading “The physician can review the virtual simulations to accept or reject the recommended surgical plan. The physician can modify surgical plans pre-operative or intraoperatively”. Given these citations it would be obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to perform the functions of Maguire and bringing in an expert to verify the performance of the automated system as disclosed in Roh. Applicant also argues that the references are improperly combined due to the allegation that the expert review as disclosed in Roh would destroy the fully autonomous principles of Maguire. However, the full automation in Maguire is not essential to the functionality of the invention but rather a perceived benefit by the inventor. Simply bringing in a human to verify the operation of the device in Maguire would not interfere with the functionality of Maguire’s invention, it would only tag an extra step to the end that one of ordinary skill in the art could easily arrive at in light of Roh’s disclosure. For at least the aforementioned reasons, the claims remain rejected under 35 USC 103 . Conclusion 07-40 AIA 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 GABRIEL VICTOR POPESCU whose telephone number is (571)272-7065. The examiner can normally be reached M-F 8AM-5PM. 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, Anne 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. 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /GABRIEL VICTOR POPESCU/Examiner, Art Unit 3797 /SERKAN AKAR/Primary Examiner, Art Unit 3797 Application/Control Number: 18/499,179 Page 2 Art Unit: 3797 Application/Control Number: 18/499,179 Page 3 Art Unit: 3797 Application/Control Number: 18/499,179 Page 4 Art Unit: 3797 Application/Control Number: 18/499,179 Page 5 Art Unit: 3797 Application/Control Number: 18/499,179 Page 6 Art Unit: 3797 Application/Control Number: 18/499,179 Page 7 Art Unit: 3797 Application/Control Number: 18/499,179 Page 8 Art Unit: 3797 Application/Control Number: 18/499,179 Page 9 Art Unit: 3797 Application/Control Number: 18/499,179 Page 10 Art Unit: 3797
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