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 .
Response to Arguments
Applicant's arguments filed 06/11/2026 have been fully considered but they are moot in view of the new grounds of rejection.
Allowable Subject Matter
Claim(s) 4 and 11 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 2018/0161543) in view of Notten (US 2024/0130708, PCT Filed Oct. 26, 2020).
Regarding claims 1, 9, and 12, Burkholz discloses a vascular access system comprising: a vascular access device comprising a catheter adapter and a catheter extending from the catheter adapter, the catheter having a distal tip configured to be inserted into a patient’s vasculature and a securement dressing ([0022]: “catheter securement dressing” adapts the positioning of a catheter, the catheter having a distal end to be inserted into the vasculature, [0029]: “vein”). Burkholz does not explicitly disclose an ultrasound assembly comprising an ultrasound probe that is configured to be positioned on the patient’s skin overtop the distal tip of the catheter while the catheter remains inserted into the patient’s vasculature, and that the securement dressing is sized and shaped to cover and secure the ultrasound probe and the catheter adapter against the patient’s skin to retain the ultrasound probe overtop the distal tip of the catheter, 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 to generate display content that includes at least some of the ultrasound images and one or more catheter-status parameters during an indwell period of the catheter. However, Notten teaches a skin-patch ultrasound imaging device that may be used to guide the positioning of a catheter within the vasculature ([0191]…[0197]: “guiding a procedure, such as positioning a catheter; monitoring the outcome of a procedure…”). 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 patch of Notten to the adapter and securement device of Burkholz, as to provide visual guidance towards the insertion of a catheter.
Regarding claims 2 and 10, Burkholz does not explicitly disclose an ultrasound assembly including a cable that connects the ultrasound probe to the base unit. However, Notten teaches a wired ultrasound probe (Fig. 4 shows a wire). 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 wired device of Notten, as to provide a conventionally means of communicating with an electronic device.
Regarding claims 5-8, 13, and 14, Burkholz does not explicitly disclose that a base unit is configured to generate display content from the ultrasound images and the readings and transmit the display content to one or more monitoring devices, wherein the content includes parameters that display catheter geometry or position, and movement or displacement. However, Notten teaches a skin-patch ultrasound imaging device that may be used to guide the positioning of a catheter within the vasculature ([0191]…[0197]: “guiding a procedure, such as positioning a catheter; monitoring the outcome of a procedure…”). 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 patch of Notten to the adapter and securement device of Burkholz, as to provide visual guidance towards the insertion of a catheter.
Regarding claim 17, Burkholz does not explicitly disclose processing ultrasound images to determine one or more catheter-status parameters comprises determining blood or fluid administration flow characteristics during an indwell period. However, Notten teaches an ultrasound imaging device that may be used to guide the positioning of a catheter within the vasculature, wherein the flow of blood may be visually monitored in the ultrasound imaging for change as the catheter is being inserted ([0191]…[0197]: “guiding a procedure, such as positioning a catheter; monitoring the outcome of a procedure…”). 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 monitoring of Notten to the adapter and securement device of Burkholz, as to provide visual guidance towards the insertion of a catheter.
Regarding claim 18, Burkholz does not explicitly disclose processing ultrasound images to determine the one or more parameters comprises detecting a procedural event during an indwell period. However, Notten teaches an ultrasound imaging device that may be used to guide the positioning of a catheter within the vasculature ([0191]…[0197]: “guiding a procedure, such as positioning a catheter; monitoring the outcome of a procedure…”). 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 procedural event detection of Notten to the adapter and securement device of Burkholz, as to provide visual guidance towards the insertion of a catheter.
Regarding claim 19, Burkholz does not explicitly disclose that the display content includes a transverse view and a cross-sectional view of the catheter within the patient’s vasculature. However, Notten teaches that ultrasound data may be in two planes located on either side of a primary perpendicular plane, providing a cross-sectional view ([0052]). 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 plane images of Notten to the device of Burkholz, as to provide robust imaging.
Claim(s) 3 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 2018/0161543) in view of Notten (US 2024/0130708, PCT Filed Oct. 26, 2020), as applied to claims 1 and 9 above, in view of Hageman (US 2018/028159, of record).
Regarding claims 3 and 21, neither Burkholz nor Notten 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 ultrasound probe of Burkholz and Notten, as to provide robust wireless communications for an ultrasound probe.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 2018/0161543) in view of Notten (US 2024/0130708, PCT Filed Oct. 26, 2020), 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 Burkholz nor Notten explicitly disclose processing ultrasound images to determine the 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”). 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 ultrasound probe of Burkholz and Notten, as to provide robust image-based detection of venous anomalies.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 2018/0161543) in view of Notten (US 2024/0130708, PCT Filed Oct. 26, 2020), as applied to claim 12 above, in view of “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).
Regarding claim 16, neither Burkholz nor Notten explicitly disclose processing ultrasound images to determine the one or more catheter-status parameters comprises detecting thrombus or phlebitis during an indwell period. However, Saugel teaches that determining one or more catheter-status parameters comprises detecting thrombus using ultrasound during the indwell period (Fig. 7: “use compression ultrasound to exclude venous thrombosis”). 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 detection of Saugel to the imaging of Burkholz and Notten, as to provide robust detection.
Regarding claim 17, neither Burkholz nor Notten explicitly disclose determining one or more parameters of determining blood administration. However, Saugel teaches that determining one or more catheter-status parameters comprises determining blood administration flow characteristics (Fig. 7: “confirm the patency of the vein and to quantify blood flow”). 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 monitoring of Saugel to the ultrasound device of Burkholz and Notten, as to provide robust monitoring.
Conclusion
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.
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/JASON M IP/Primary Examiner, Art Unit 3793
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