DETAILED ACTION
Notice of 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/27/2026 has been entered.
Response to Arguments
Applicant's arguments filed 08/27/2026 have been fully considered but they are not persuasive and moot in view of the new grounds of rejection under Lange (US 2017/0000974).
Concerning some of the amendments that have been made, the ultrasound probe that was taught is indeed retained because it is held in some manner, the catheter is within the patient during an “indwell period” because the catheter is dwelling within the body, and the ultrasound probe does teach a “sequence of images” since the probe is performing imaging.
To further clarify what the prior art teaches, the reference Lange is being introduced.
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 may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim(s) 1, 2, 5-10, 12-14, 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Ultrasound-guided central venous catheter placement: a structured review and recommendations for clinical practice” by B. Saugel et al. Critical Care. 21:225, pp.1-11, 2017 (Saugel, of record), in view of, “Assistive technology for ultrasound-guided central venous catheter placement” by M. Ikhsan et al. J Med Ultraso. 45:41-57, 2018 (Ikhsan, of record) in view of Lange (US 2017/0000974).
Regarding claims 1, 9, and 12, Saugel discloses a vascular access system and method of monitoring, comprising: a vascular access device comprising a catheter extending from a catheter adapter (“guide wire” may be a catheter adapter), the catheter having a distal tip configured to be inserted into a patient’s vasculature; an ultrasound assembly comprising an ultrasound probe, the ultrasound probe being configured to be positioned and retained on the patient’s skin overtop the distal tip of the catheter while the catheter remains inserted into the patient's vasculature; and a base unit comprising communication circuitry configured to communicate with the ultrasound probe and an image processor configured to process ultrasound images received from the ultrasound probe (Figs. 5 and 7: ultrasound imaging device is wired and provides images of an inserted catheter’s position to confirm proper placement). Saugel does not explicitly disclose that the ultrasound assembly comprises a sensor array, integrated with the ultrasound probe, configured to generate sensor readings pertaining to the patient’s tissue surrounding the distal tip of the catheter, wherein the sensor readings are used to generate display content that includes both ultrasound images and one or more catheter-status parameters during an indwell period of the catheter. However, Ikhsan teaches a camera that is attached to an ultrasound assembly that captures overlaid images of a device insertion procedure which would provide readings pertaining to tissue surrounding the distal tip of the catheter (Fig. 4: “displayed as an overlay on the ultrasound image”). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the image capturing device of Ikhsan to the ultrasound assembly of Saugel, as to provide robust bi-modal sensing. While it is not explicitly disclosed that a securement dressing is used to cover and secure the probe, sensor, and catheter against the patient’s skin, Saugel does teaches a securement dressing shaped to cover and secure the ultrasound probe and other devices against a patient’s skin (Fig. 1). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply a conventional dressing to the combined devices of Saugel and Ikhsan, as to provide a well-known and conventional securing means. Neither Saugel nor Ikhsan explicitly disclose that there is an ‘indwell’ period during the acquisition of ultrasound images. However, Lange teaches positioning and guiding an indwelling device using external ultrasound imaging (Fig. 5A, [0022], [0062], [0080], [0081]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the ultrasound-guided monitoring of Lange to the catheter placement of Saugel and Ikhsan, as to provide an accurate positioning of an indwelling catheter.
Regarding claims 2 and 10, both Saugel and Ikhsan teach wired connections between ultrasound assembly and processing electronics (Saugel @ Figs. 5 and 7; Ikhsan @ Fig. 4).
Regarding claims 5-8, 13, 14, both Saugel and Ikhsan teach transmitting display content to a monitoring device, and generating, through a base unit, a catheter-status parameter in the form of its position, movement, or displacement from both ultrasound images and sensor readings for the catheter or line draw tubing (Saugel @ Figs. 5 and 7; Ikhsan @ Fig. 4 – ultrasound images capture in vivo position/movement, sensor readings capture in vitro position/movement).
Regarding claim 16, Saugel discloses that determining one or more catheter-status parameters comprises detecting thrombus (Fig. 7: “use compression ultrasound to exclude venous thrombosis”). While it is not explicitly disclosed that additional sensor readings are used to make this determination, the skin images of Ikhsan would be able to detect thrombus. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the sensor of Ikhsan to the detection of Saugel, as to provide an accurate determination of a catheter’s status.
Regarding claim 17, Saugel discloses that determining one or more parameters comprises determining blood administration flow characteristics (Fig. 7: “confirm the patency of the vein and to quantify blood flow”). While it is not explicitly disclosed that additional sensor readings are used to make this determination, the skin images of Ikhsan would be able to detect blood flow characteristics (e.g. hemorrhage, contusion). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the sensor of Ikhsan to the detection of Saugel, as to provide an accurate determination of a catheter’s status.
Regarding claim 18, Saugel discloses that determining one or more parameters comprises detecting a procedural event (Fig. 7: both proper and improper placement are considered to be a “procedural event”). While it is not explicitly disclosed that additional sensor readings are used to make this determination, the skin images of Ikhsan would be able to detect blood flow characteristics (e.g. hemorrhage, contusion). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the sensor of Ikhsan to the detection of Saugel, as to provide an accurate determination of a catheter’s status.
Claim(s) 3, 4, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Ultrasound-guided central venous catheter placement: a structured review and recommendations for clinical practice” by B. Saugel et al. Critical Care. 21:225, pp.1-11, 2017 (Saugel, of record), in view of, “Assistive technology for ultrasound-guided central venous catheter placement” by M. Ikhsan et al. J Med Ultraso. 45:41-57, 2018 (Ikhsan, of record) in view of Lange (US 2017/0000974), as applied to claims 1 and 9 above, in view of Hageman (US 2018/028159, of record).
Regarding claim 3, neither Saugel, Ikhsan, nor Lange, explicitly disclose wirelessly connecting the ultrasound probe and sensor to a base unit. However, Hageman teaches wireless transmission from an ultrasound probe to an external receiver ([0042]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the wireless ultrasound probe of Hageman to the system of Saugel, Ikhsan, and Lange, as to provide a robust wireless configuration of an ultrasound probe.
Regarding claims 4 and 11 neither Saugel, Ikhsan, nor Lange, explicitly disclose a securement dressing that is configured to secure the ultrasound probe and the sensor array overtop the catheter. However, Hageman teaches a dressing that provides securement of the probe housing to a patient’s skin ([0042]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the dressing of Hageman to the system of Saugel, Ikhsan, and Lange, as to provide a robust securing means for an ultrasound probe housing.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Ultrasound-guided central venous catheter placement: a structured review and recommendations for clinical practice” by B. Saugel et al. Critical Care. 21:225, pp.1-11, 2017 (Saugel, of record), in view of, “Assistive technology for ultrasound-guided central venous catheter placement” by M. Ikhsan et al. J Med Ultraso. 45:41-57, 2018 (Ikhsan, of record) in view of Lange (US 2017/0000974), as applied to claim 12 above, in view of “Confirming extravasation from a peripheral venous catheter: another role for ultrasonography” by J. Dolan. Anaesthesia. 2012 (Dolan, of record).
Regarding claim 15, neither Saugel, Ikhsan, nor Lange, explicitly disclose determining one or more catheter-status parameters comprises detecting extravasation or infiltration. However, Dolan teaches detecting extravasation using ultrasound (Fig 1: “Velocity colour Doppler confirming fluid extravasation”). Ikhsan’s sensor images would detect extravasation as it would manifest itself in the skin of the subject. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the extravasation detection of Dolan to the system of Saugel, Ikhsan, Lange, as to provide robust image-based detection of venous anomalies.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Ultrasound-guided central venous catheter placement: a structured review and recommendations for clinical practice” by B. Saugel et al. Critical Care. 21:225, pp.1-11, 2017 (Saugel, of record), in view of, “Assistive technology for ultrasound-guided central venous catheter placement” by M. Ikhsan et al. J Med Ultraso. 45:41-57, 2018 (Ikhsan, of record) in view of Lange (US 2017/0000974), as applied to claim 12 above, in view of Wekselman (US 20240074725).
Regarding claim 19, neither Saugel, Ikhsan, Lange explicitly disclose generating an alert when a condition or event is detected from the sequence of ultrasound images or the sensor readings during the indwell period. However, Wekselman teaches generating a warning during an ultrasound guided needle insertion ([0049], Fig. 7). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the warning of Wekselman to the monitoring of Saugel, Ikhsan, Lange, as to provide a safety mechanism during instrument advancement.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Ultrasound-guided central venous catheter placement: a structured review and recommendations for clinical practice” by B. Saugel et al. Critical Care. 21:225, pp.1-11, 2017 (Saugel, of record), in view of, “Assistive technology for ultrasound-guided central venous catheter placement” by M. Ikhsan et al. J Med Ultraso. 45:41-57, 2018 (Ikhsan, of record) in view of Lange (US 2017/0000974), as applied to claim 9 above, in view of Cohen (US 2008/0255451, of record).
Regarding claim 21, neither Saugel, Ikhsan, Lange, explicitly disclose that establishing the connection comprises wirelessly coupling a wireless adapter of the ultrasound assembly to the base unit. However, Cohen teaches an ultrasound probe that wirelessly transmits its signals to be processed in a base unit (Abstract). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the wireless capability of Cohen to the ultrasound probe of Saugel, Ikhsan, Lange, as to provide robust wireless capabilities that eliminates up the space and inconvenience of a cable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Ip whose telephone number is (571) 270-5387. The examiner can normally be reached Monday - Friday 9a-5p 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, Christopher Koharski can be reached on (571) 272-7230. 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.
/JASON M IP/Primary Examiner, Art Unit 3797
Prosecution Insights