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 Claims 1-14 are withdrawn, and Claims 15-20 have
been examined on the merits.
Election/Restrictions
Applicant’s election without traverse of claims 15-20 drawn to Invention III in the reply filed on 04/30/2026 is acknowledged.
Claims 1-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being
drawn to a nonelected Invention I drawn to a method of guiding intravenous catheter insertion, and Invention III drawn to a system of guiding intravenous catheter insertion for a patient, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation “a communication connection coupled to an ultrasound device”. It is unclear what a communication connection is and the purposes it serves. For purposes of examination, the limitation will be construed as any device, which can display the ultrasound information from the ultrasound device, thereby communicating the information to the user (i.e. a display). However, further clarification is required.
Claim 20 recites the limitation “automatically updating an inventory system associated with the plurality of catheters”. It is unclear what is meant by the inventory system and thus unclear how this is an automated system. For purposes of examination, the limitation will be construed as systems that are automatically updated or adapted to fit the selected catheter. However, further clarification is required.
All remaining claims are rejected due to their dependency to the independent claim.
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 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Prince (US20210085282A1, disclosed in Applicant IDS) in view of Yarmush (WO2020076942A2).
Regarding Claim 15,
Prince teaches a system of guiding an intravenous catheter insertion for a patient (corresponding disclosure in at least [0007], where the system is for guiding the catheter insertion “The enhanced image of the ultrasound image further includes a guideline indicating a predicted trajectory of the cannula through the subcutaneous portion of the patient”), the system comprising:
a communication connection 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”)
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 [0057], where there is a notification device, or the alerts, for providing instructions “visual alerts can include LED lights, indicators, or the like, operably connected with the system 10 that visually alert the clinician. Audible alerts can include sounds, instructions, alarms, or the like” and further in [0059], where instructions include instructions for guiding or determining if the catheter (cannula) is on trajectory “the system 10 can display a predicted trajectory of the cannula by the guideline 712, or range of trajectory, relative to the target vessel 50, and indicate with colors, patterns, or instructions displayed proximate thereto if the cannula is on course to access the target vessel”); 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 [0036], where the instructions are on a computer medium “Logic (or a component) may be in the form of one or more software modules, such as executable code in the form of an operating system component, an executable application, firmware, an application programming interface (API), one or more subroutines, a function, a procedure, an applet, a plug-in, a servlet, a Component Object Model (COM) object, a routine, source code, object code, a shared library/dynamic linked library, a script, or one or more instructions. These software modules may be stored in any type of a suitable non-transitory storage medium, or transitory storage medium (e.g., electrical, optical, acoustical, or other form of propagated signals such as carrier waves, infrared signals, or digital signals)”), the method comprising:
receiving a first set of real-time ultrasound data associated with the patient from the ultrasound device prior to an insertion of an intravenous catheter (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 further in [0062], where the data is prior to the insertion of the catheter “advantageously, embodiments disclosed herein, or combinations thereof, can provide a clear, quantitative indication of suitable vessels to target prior to any insertion of the cannula”);
identifying a plurality of anatomical structures of the patient from the first set of real-time ultrasound data (corresponding disclosure in at least [0050], where the plurality of anatomical structures, or the vessels, are determined based off of the ultrasound images “, the enhanced image depicted on the display 30 indicates a first icon 250A highlighting the target vessel 50. To note, the system 10 autonomously identifies one or more target vessels within the image and positions one or more icons surrounding the one-or-more target vessels”)
using a machine learning model trained with a set of training data comprising a plurality of historical ultrasound data, the plurality of anatomical structures comprising at least one blood vessel;
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”).
Prince does not teach selecting the intravenous catheter from a plurality of catheters based at least in part on the first set of real-time ultrasound data, using a machine learning model trained with a set of training data comprising a plurality of historical ultrasound data, and selecting an insertion site based on the first blood flow velocity rate and one or more other parameters from the first set of real-time ultrasound data.
Yarmush, in a similar field of endeavor, teaches a similar concept (locating vessels and catheters) of selecting the intravenous catheter from a plurality of catheters based at least in part on the first set of real-time ultrasound data (corresponding disclosure in at least [0132], where a catheter is selected from multiple types of catheters “ the cannulation device may be designed to receive several different types of cannulating instruments”)
using a machine learning model trained with a set of training data comprising a plurality of historical ultrasound data (corresponding disclosure in at least [0129], where historical ultrasound data, or previously collected data is used “The algorithm may be trained on logged data recorded from previous puncture attempts from the same device or similar devices. The logged data may include an indication of whether the attempt was successful or unsuccessful, as well as other collected data including, but are not limited to, image data (e.g., ultrasound information to track vessel movement”),
and selecting an insertion site based on the first blood flow velocity rate and one or more other parameters from the first set of real-time ultrasound data (corresponding disclosure in at least [0059], where using the ultrasound data, the insertion site, or the vessel, is selected “ These imaging techniques may be used to detect the presence and direction of blood flow within vessels, so that a suitable vessel for puncture may be selected”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated selecting a catheter from multiple catheters, using machine learning with training data comprising historical ultrasound data, and selecting an insertion site based on the blood flow rate as taught by Yarmush. One of the ordinary skill in the art would have been motivated to incorporate this because all of the steps are tied towards an efficient and automated method of determining an optimal trajectory and site for inserting a catheter, preventing failed insertion attempts into the patient.
Regarding Claim 16, Prince and Yarmush 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, Prince and Yarmush 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, Prince and Yarmush 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 19, Prince and Yarmush teach the limitations of Claim 15, and further teaches an ultrasound data store (corresponding disclosure in at least [0036] of Prince, where a storage device is disclosed for ultrasound data “These software modules may be stored in any type of a suitable non-transitory storage medium, or transitory storage medium (e.g., electrical, optical, acoustical, or other form of propagated signals such as carrier waves, infrared signals, or digital signals”) storing a plurality of historical ultrasound data (corresponding disclosure in at least [0129] of Yarmush, where there is historical ultrasound data used “The algorithm may be trained on logged data recorded from previous puncture attempts from the same device or similar devices. The logged data may include an indication of whether the attempt was successful or unsuccessful, as well as other collected data including, but are not limited to, image data (e.g., ultrasound information to track vessel movement”)).
Regarding Claim 20, Prince and Yarmush teach the limitations of Claim 15, and further teaches wherein the method further comprises: responsive to selecting the intravenous catheter from the plurality of catheters, automatically updating an inventory system associated with the plurality of catheters (corresponding disclosure in at least [0131], where depending on the selected catheter type, the inventory or the various algorithms and systems are automatically updated to adjust “Thus, instead of recognizing vessel roll after the fact, the machine learning algorithm can predict in advance that the vessel is likely to roll out of the trajectory, and may immediately adjust the trajectory of the cannulation instrument with the target vessel in order to minimize the likelihood of the vessel roll actually occurring” and further in [0132], where the adjustment is based on the particular application, or the selected catheter (instrument) type “The instrument may be, for example, a needle or catheter, depending on the particular application at a given time. Additionally, the cannulation device may be designed to receive several different types of cannulating instruments”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Such prior arts include Yang (WO2023027733A1) regarding locating blood vessels, determining blood flow, and placing catheters, Misener (WO2022119856A1) regarding locating blood vessels with machine learning and catheter placement, and Cox (US10342575B2) regarding needle insertion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN KIM whose telephone number is (571)272-1821. The examiner can normally be reached Monday-Friday 6-2 PST.
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. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.E.K./Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
Prosecution Insights