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 .
Status of Claims
Claims 1-20 are pending in this application. Claims 1-14 are withdrawn, Claim 19 is cancelled, Claim 21 is newly added, and Claims 15-18 and 20-21 have been examined on the merits.
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 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Golan (US20220406460A1) in view of Prince (US20210085282A1, disclosed in Applicant IDS).
Regarding Claim 15,
Golan teaches a system of guiding an intravenous catheter insertion for a patient (corresponding disclosure in at least [0113], where the system guides where to insert the catheter “S240 can optionally additionally or alternatively include determining (e.g., predicting, recommending, etc.) features of the surgical procedure, such as a recommended path to reach an occlusion, an optimal entry point (e.g., groin, wrist, etc.) with which to insert a catheter”), the system comprising:
a notification device configured to produce one or more notifications for providing instructions to medical personnel during intravenous catheter insertion (corresponding disclosure in at least [0123], where there is a notification for instructions, or the notification recipient being notified of the treatment “and triggering one or more actions (e.g., notification at an application of the recipient which includes a treatment option recommendation, referencing an inventory database to check for availability of a recommended device”),
at least one processor; and one or more non-transitory computer-readable media that store computer-executable instructions that, when executed by the at least one processor perform a method of guiding intravenous catheter insertion for the patient(corresponding disclosure in at least [0140], where there is a processor and storage system “Additional or alternative embodiments implement the above methods and/or processing modules in non-transitory computer-readable media, storing computer-readable instructions. The instructions can be executed by computer-executable components integrated with the computer-readable medium and/or processing system”), the method comprising:
receiving a first set of ultrasound data associated with the patient from the ultrasound device prior to an insertion of an intravenous catheter (corresponding disclosure in at least [0125], where training data is received and the machine learning model is used “ the method includes: receiving a set of (e.g., CT, CTA, etc.) images; processing the set of images with a set of trained (e.g., machine learning, deep learning, etc.) models and/or algorithms to segment a set of vessels from the set of images”)
accessing a catheter inventory data store storing catheter information corresponding to a plurality of catheters, the catheter information comprising at least one of a catheter length, a catheter gauge, and a catheter type (corresponding disclosure in at least [0110], where there is a data storage with multiple types of catheter information, including the size and type “Selecting the medical device can include any or all of: a type of medical device, features (e.g., size, material composition, features, etc.) of a medical device, and/or any other information. In some variations, for instance, S240 can include selecting any or all of: a catheter diameter (e.g., based on vessel diameter, based on smallest vessel diameter, based on vessel diameter immediately before the occlusion, etc.), a catheter length (e.g., based on path length, based on length of one or more vessels, etc.), a catheter material (e.g., catheter flexibility based on vessel tortuosity), a catheter type (e.g., twist end catheter, suction catheter, etc.)” and further in [0119], where the information is stored within a database “ referencing an inventory database can function to determine which devices are available for selection, such that an optimal device which is available based on the inventory database can be recommended and/or suggested to the user”)
determining, from the first set of ultrasound data, at least one vessel parameter of the blood vessel (corresponding disclosure in at least [0095], where using imaging (e.g., ultrasound), a vessel parameter (e.g., diameter) is determined “The parameters can be associated with (e.g., characterize, define, etc.) any or all of: a pathological region and/or feature (e.g., clot size, aneurysm size, fracture location, etc.); a non-pathological region and/or feature (e.g., vessel diameter proximal to a detected occlusion, vessel diameter of a vessel needed to access an occlusion and/or aneurysm, etc.)”
selecting an intravenous catheter from the plurality of catheters based at least in part on the at least one vessel parameter and the catheter information (corresponding disclosure in at least [0110], where based on the vessel parameter and catheter information, a catheter is selected “Selecting the medical device can include any or all of: a type of medical device, features (e.g., size, material composition, features, etc.) of a medical device, and/or any other information. In some variations, for instance, S240 can include selecting any or all of: a catheter diameter (e.g., based on vessel diameter, based on smallest vessel diameter, based on vessel diameter immediately before the occlusion, etc.)”),
identifying a plurality of anatomical structures of the patient from the first set of ultrasound data using the machine learning model with a set of training data comprising a plurality of historical ultrasound data, the plurality of anatomical structures comprising the at least one blood vessel (corresponding disclosure in at least [0136], where anatomical structures are identified from the machine learning model “the sets of models and/or algorithms to be used in checking for a set of suspected conditions can be selected based on features in the set of data, such as, but not limited to, a type of image data (e.g., CT vs. MRI vs. ultrasound), metadata associated with the image data (e.g., indicating the anatomical region being imaged” and further in [0125], where the anatomical structure includes vessels “ receiving a set of (e.g., CT, CTA, etc.) images; processing the set of images with a set of trained (e.g., machine learning, deep learning, etc.) models and/or algorithms to segment a set of vessels from the set of images; analyzing the segmented vessels to determine a set of diameters associated with the segmented vessels and/or any other regions associated with the images”);
estimating a first blood flow velocity rate associated with the at least one blood vessel based on the first set of real-time ultrasound data; and
selecting an insertion site based on the first blood flow velocity rate and the at least one vessel parameter (corresponding disclosure in at least [0113], where an insertion point is proposed based on the vessel parameter and “S240 can optionally additionally or alternatively include determining (e.g., predicting, recommending, etc.) features of the surgical procedure, such as a recommended path to reach an occlusion, an optimal entry point (e.g., groin, wrist, etc.) with which to insert a catheter”
Golan does not teach wherein the system is communicatively coupled to an ultrasound device and the use of real-time ultrasound data, and estimating a first blood flow velocity rate associated with the at least one blood vessel based on the first set of real-time ultrasound data.
Prince, in a similar field of endeavor, teaches a similar concept (insertion of catheters) of
the system is communicatively coupled to an ultrasound device (corresponding disclosure in at least [0037], where there is a communication connection, or a cable connected to a console “the ultrasound probe 12 is operably connected to the console 20 via a cable 31, though in an embodiment the ultrasound probe 12 can be wirelessly connected thereto”)
and real-time ultrasound data (corresponding disclosure in at least [0005], where multiple real-time ultrasound data (multiple ultrasound images which are updated regarding the vessel, the flow, etc.) “receiving updated information further includes measuring at least one of a Doppler information or a pulsatile information. The first icon in the updated state further includes determining a flow rate of the target vessel. The first icon in the updated state further includes determining a venous or arterial flow of the target vessel”) and
estimating a first blood flow velocity rate associated with the at least one blood vessel based on the first set of real-time ultrasound data (corresponding disclosure in at least [0056], where blood flow rate, which is obtained via a Doppler system, is determined from the data “the system 10 includes Doppler measurements, pulsatile measurements, combinations thereof, or the like to determine if the vessel has sufficient flow for a procedure. As shown in FIG. 5A, a first icon 550A indicates a first target vessel has sufficient flow (“good flow”) using a first color, pattern, label, or combinations thereof”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated real-time ultrasound data and estimating a blood flow velocity rate as taught by Prince. One of the ordinary skill in the art would have been motivated to incorporate this because the real-time ultrasound data provides updated measurements of the vessels for more accurate information regarding the insertion site.
Regarding Claim 16, Golan and Prince teach the limitations of Claim 15, and Prince further teaches wherein the notification device comprises: one or more displays configured to produce a visual notification for the medical personnel (corresponding disclosure in at least [0047], where there is a display for visualization of notifications “the display 30 depicts an enhanced ultrasound image including an imaged subcutaneous portion of a patient, and one or more icons each surrounding a target area, for example a target vessel 50. The system 10 autonomously determines target structures within the image and positions the icon accordingly. The icon can identify potential target vessels within the image and clearly distinguish these vessels from surrounding structures to make them easily and quickly identifiable. The icon includes one or more colors, patterns, intermittent (“flashing” or “blinking”) features, alphanumeric symbols, combinations thereof, or the like, to further distinguish the target vessel 50 from surrounding imaged structures”).
Regarding Claim 17, Golan and Prince teach the limitations of Claim 16, and Prince further teaches wherein the visual notification comprises positioning instructions for inserting the intravenous catheter including a suggested angle of insertion for the intravenous catheter (corresponding disclosure in at least [0061], where the system will notify the user regarding the insertion trajectory of the catheter “the system 10 can provide additional icons to identify potential obstructions between the target vessel 50 and the cannula 40. For example, a nerve bundle 52, or an arterial vessel 54, or the like, can be disposed between the target vessel 50 and the cannula 40. The system 10 can provide icons including different colors, patterns, labels, or the like, from that of icons highlighting the target vessels 50 to indicate to the clinician that an alternate path to the target vessel is required. The system 10 can further display additional visual, audible, or tactile alerts to notify the clinician of the obstruction” and further in [0052], where alternatively, the system notifies the user of the insertion angle of the catheter with the display “he system 10 can measure the depth of the target vessel relative to the skin surface and, together with information on the cannula size 60 of the cannula being used and the angle of insertion 64, determine a vessel purchase length for the target vessel. For example, as shown, the first icon 350A highlights the first target vessel 50A, and determines a vessel purchase length of 4 cm”).
Regarding Claim 18, Golan and Prince teach the limitations of Claim 16, and Prince further teaches wherein the notification device further comprises: one or more speakers configured to produce an audible notification for the medical personnel, the audible notification comprising positioning instructions for inserting the intravenous catheter (corresponding disclosure in at least [0060], where the system will provide audio alerts, which will indicate the position of the catheter, thereby instructing the user to reposition the catheter “he system 10 can provide visual, audible, or tactile alerts, as described herein, to indicate the cannula can potentially be inserted through a far wall of the vessel, termed “backwalling.” The cannula tip 42 can be represented as an image, symbol, icon, or the like, and can be depicted with a distinct color, pattern, highlighted, or “flashing,” to indicate a proximity to “backwalling” the vessel”).
Regarding Claim 20, Golan and Prince teach the limitations of Claim 15, and Golan further teaches wherein the method further comprises: responsive to selecting the intravenous catheter from the plurality of catheters, automatically updating the catheter inventory data store (corresponding disclosure in at least [0119], where the catheter inventory storage is automatically updated “S240 can include automatically referencing (e.g., checking) an inventory database associated with any or all of: a user (e.g., specialist), the patient (e.g., inventory associated with the healthcare facility at which the patient is currently located and/or en route to), a healthcare facility (e.g., healthcare facility at which a specialist is located, healthcare facility at which the patient is located, healthcare facility at which the patient will receive treatment, etc.), and/or any other inventory database… referencing an inventory database can function to determine which devices are available for selection”; when a catheter is used, that catheter is no longer available, which is ultimately indicated by the databases available).
Regarding Claim 21, Golan and Prince teach the limitations of Claim 15, and Golan further teaches wherein the intravenous catheter is selected from the plurality of catheters based further in part on the first blood flow velocity rate (corresponding disclosure in at least [0128], where the catheter is selected based on the blood flow rate “automatically determining a recommendation of any or all of: … a device type; a non-surgical intervention (e.g., tPA); a combination of surgical and non-surgical interventions; a timing of treatments; and/or any other recommendations. The recommendation is preferably determined based at least on an analysis of a set of images (e.g., CT images), such as based on any or all of: a location of the clot… blood flow information (e.g., flow rates proximal to occlusion), and/or any other features” and further in [0110], where the type of devices included is a catheter “S240 can include selecting any or all of: … a device type (e.g., catheter, revascularization device, coil, braid, aspiration system, etc.)”).
Response to Arguments
Applicant's arguments filed 08/13/2026 regarding the 35 U.S.C. 112b rejections have been fully considered and the rejections are withdrawn in light of the amendments.
Applicant’s arguments with respect to the 35 U.S.C. 103 rejections 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.
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.
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/K.E.K./Examiner, Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
