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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-20) in the reply filed on May 20, 2026 is acknowledged.
Claim 21 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 20, 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 15, 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The information disclosure statement (IDS) submitted on December 13, 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The information disclosure statement (IDS) submitted on July 9, 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The information disclosure statement (IDS) submitted on January 23, 2026 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-7, 9-15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schloesser et al. (WO 2019228991), hereinafter Schloesser.
Regarding claim 1, Schloesser discloses a smart intravenous catheter (IVC) assembly (Fig. 2, catheter 110) including: a stabilization platform (Fig. 2, wings 150a-b) configured to hold an IVC in a fixed position relative to tissue of a patient (Fig. 3 and [0062], wings may be configured to attach the catheter 110 to the patient's hand); and a sensor module (Fig. 2, sensor module 106) mechanically supported by the stabilization platform (Fig. 2 and [0148], sensor 106 is supported on the wings 150a-b), the sensor module including: at least one sensor configured to sense a physical characteristic of the tissue of the patient and produce sensed data representing the physical characteristic of tissue of the patient (Fig. 2 and [00151], sensor module 106 comprises 1 or more sensors for sensing various patient conditions, such as local temperature of the tissue, and producing data representing said characteristic for transmission), and a transceiver configured to transmit the sensed data to a smart device remote from the stabilization platform (Fig. 1 and [0010, 00145], module 114 integrated into sensor module 106 is configured to communicate the data sensed by the one or more sensors to a local (remote) smart device 120).
Regarding claim 3, Schloesser discloses the smart intravenous catheter (IVC) assembly according to claim 1, wherein the at least one sensor includes at least one of a temperature sensor ([0049,00142], sensor may be a temperature sensor), a NIR emitter, a photodiode, a pressure sensor, a biosensor, or an optical flow sensor for sensing the physical characteristic of the tissue of the patient.
Regarding claim 4, Schloesser discloses the smart intravenous catheter (IVC) assembly according to claim 1,wherein the sensor module is mounted to a portion of the stabilization platform between the IVC and the tissue of the patient to position the at least one sensor a fixed distance from the tissue of the patient (Fig. 2 and [0148], sensor module 106 is shown mounted to bottom surface of wings 150 (Fig. 2 is a bottom view of device), thus between the IVC 110 and the patient, and may be positioned a fixed distance from patient tissue when IVC is attached to patient).
Regarding claim 5, Schloesser discloses the smart intravenous catheter (IVC) assembly according to claim 1,wherein the at least one sensor is mounted directly on the sensor module (Fig. 2 and [00148, 00151], sensors make up the sensor module 106, and are thus mounted directly on the module on the wings 150a-b) or is remotely connected to the sensor module.
Regarding claim 6, Schloesser discloses the smart intravenous catheter (IVC) assembly according to claim 1, wherein sensor module is at least one of coated with an antimicrobial coating, encapsulated in medical grade shrink wrap, or encapsulated in a hermetically sealed housing ([0091], electronic sensing module may be surrounded with cover sleeve to seal module from exposure to external environment (hermetic sealing)).
Regarding claim 7, Schloesser discloses the smart intravenous catheter (IVC) assembly according to claim 1, wherein the stabilization platform includes: a base portion for stabilizing the stabilization platform against the tissue of the patient (Fig. 2 and 4 and [0062], wing portions 150a and 150b for stabilizing device against skin), and a ramp portion for holding the IVC at a fixed position and a fixed angle relative to the tissue of the patient (Fig. 4 and [00148], ramped portion which attaches wings 150a and 150b to the hub body 156 for holding tube 152 of IVC as fixed position/angle).
Regarding claim 9, Schloesser discloses the smart intravenous catheter (IVC) assembly according to claim 1,wherein the stabilization platform includes wings that extend laterally to stabilize the stabilization platform against the tissue of the patient (Fig. 2 and 4 and [0062], wing portions 150a and 150b for stabilizing device against skin).
Regarding claim 10, Schloesser discloses the smart intravenous catheter (IVC) assembly of claim 9, wherein the sensor module is mounted to the wings or to a portion of the stabilization platform between the wings (Fig. 2 and 4 and [0148], sensor module 106 is mounted to portion of stabilization platform extending between wings 150a-b).
Regarding claim 11, Schloesser discloses a method for detecting IVC complications ([0019], method of detecting/displaying information using system of Fig. 1), the method including: sensing, by a sensor of a sensor module (Fig. 2 and [00151], sensor module 106 comprises 1 or more sensors for sensing) mounted to a stabilization platform holding an IVC in a fixed position relative to tissue of a patient (Fig. 2-3 and [0062, 0148], sensor 106 is supported on the wings 150a-b, wherein wings may be configured to attach to the patient's hand, holding sensor module in a fixed position relative to hand), a physical characteristic of the tissue of the patient ([00151], sensing various patient conditions, such as local temperature of the tissue); producing, by the sensor of a sensor module, sensed data representing the physical characteristic of tissue of the patient ([00151], sensor module 106 configured for producing data representing said characteristic for transmission); transmitting, by a transceiver of the sensor module, the sensed data to a smart device remote from the stabilization platform (Fig. 1 and [0010, 00145], module 114 integrated into sensor module 106 is configured to communicate the data sensed by the one or more sensors to a local (remote) smart device 120).; and outputting, by the smart device to the patient or to a caregiver, output data related to the sensed data (Fig. 1 and [0145], smart device 120 may process and display the sensed data in a report for user).
Regarding claim 12, Schloesser discloses the method of claim 11, further comprising outputting, by the smart device, at least one of the sensed data or an alert as the output data ([0162-0163], smart device 120 can use the sensed data to output a compiled data report and/or an alert regarding the sensed data).
Regarding claim 13, Schloesser discloses the method according to claim 11, further comprising transmitting, by the transceiver of the sensor module, the sensed data to an electronic reader band of the smart device worn by the patient ([0005], smart device 120 may be a smart band worn by user).
Regarding claim 14, Schloesser discloses the method according to claim 11, further comprising transmitting, by the transceiver of the sensor module, the sensed data to the smart device operated by the caregiver (Fig. 1 and [0147], the smart device 120 bay be utilized by a clinician/caregiver).
Regarding claim 15, Schloesser discloses the method according claim 11, further comprising sensing, by the sensor of the sensor module, at least one of a temperature of the tissue, an optical property of the tissue, or a biological sample of the tissue as the physical characteristic ([00151], the 1 or more sensors of sensor module 106 may sense local temperature of the tissue).
Regarding claim 17, Schloesser discloses the method according to claim 11, further comprising transmitting, by the transceiver of the sensor module, the sensed data to a medical database server for storage in a record of the patient (Fig. 1 and [0146-0147], data may be transmitted to a cloud server 130 for recording and viewing in a patient data report).
Regarding claim 18, Schloesser discloses the method according to claim 11, further comprising computing, by the sensor module or the smart device, a health status of the tissue of the patient; and outputting, by the smart device, the health status of the tissue as the output data (Fig. 1 and 8 and [0146], sensed data may be analyzed/computed by smart device and then uploaded/outputted as a health status of the patient).
Regarding claim 19, Schloesser discloses the method according to claim 11, further comprising sensing, by the sensor of the sensor module, the physical characteristic of the tissue at a location between the stabilization platform and the tissue (Fig. 2 and [0141, 0148], sensor module 106 is shown mounted to bottom surface of wings 150 (Fig. 2 is a bottom view of device), thus between the IVC 110/stabilization and the patient, thus sensing a characteristic of the tissue at location between stabilization platform and tissue).
Regarding claim 20, Schloesser discloses the method according to claim 11, further comprising sensing, by the sensor of the sensor module, the physical characteristic of the tissue at a location remote from the stabilization platform Fig. 2 and [0141, 0148], sensors of module 106 may also be within catheter tube 152 or hub 156, thus sensing tissue located remote from stabilization platform/wings 150).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Schloesser (WO 2019228991), in view of Van Schalkwyk et al. (US 20180185606), hereinafter Van Schalkwyk.
Regarding claim 2, Schloesser discloses the smart intravenous catheter (IVC) assembly of claim 1.
Schloesser fails to disclose wherein the stabilization platform includes a slot, and the sensor module includes a circuit board that is inserted into the slot. However, Van Schalkwyk discloses wherein the stabilization platform includes a slot, and the sensor module includes a circuit board that is inserted into the slot (Fig. 73 and [0576-0578], external portion of device 2342 has a retainer slot and cover 2374 for holding a PCB for the device sensors).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Schloesser to incorporate the teachings of Van Schalkwyk and modify the stabilization platform to include a slot, and the sensor module to include a circuit board that is inserted into the slot. Doing so would reduce the likelihood that any liquid would come in contact the circuit board or any other electrical components of the sensor, to aid sealing of the electrical components of the sensor (Van Schalkwyk, [0576-0578])
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Schloesser (WO 2019228991), in view of Isaacson et al. (US 20160008538), hereinafter Isaacson.
Regarding claim 8, Schloesser discloses the smart intravenous catheter (IVC) assembly of claim 1.
Schloesser fails to disclose wherein the stabilization platform is made of a flexible rubber or a flexible plastic material. However, Isaacson discloses wherein the stabilization platform is made of a flexible rubber or a flexible plastic material (Fig. 9-10 and [0078], wing attachment 24 is molded from a flexible elastomeric polymer (rubber)).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Schloesser to incorporate the teachings of Isaacson and modify the stabilization platform to be made of a flexible rubber or a flexible plastic material. Doing so would provide a wing structure which has a desirable amount of flexibility and/or rigidity (Isaacson, [0078]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Schloesser (WO 2019228991), in view of Bodewes et al. (US 20180184944), hereinafter Bodewes.
Regarding claim 16, Schloesser discloses the method according to claim 11.
Schloesser fails to disclose transmitting, by a software application on the smart device, a control signal to the sensor module, the control signal controlling the sensor module to sense the physical characteristic of the tissue of the patient and transmit the sensed data to the smart device. However, Bodewes discloses transmitting, by a software application on the smart device, a control signal to the sensor module, the control signal controlling the sensor module to sense the physical characteristic of the tissue of the patient and transmit the sensed data to the smart device ([0092,0094], communication chip 130 which, as instructed by external device software, transmits control signals to sensors 134-136 of device to record measurements, and transmit sensor signals back to chip 130/external device).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Schloesser to incorporate the teachings of Bodewes and modify the method to include transmitting, by a software application on the smart device, a control signal to the sensor module, the control signal controlling the sensor module to sense the physical characteristic of the tissue of the patient and transmit the sensed data to the smart device/ Doing so would enable bidirectional wireless signal transmission between the sensors and the external device, while also reducing power consumption of the device by only activating the sensor when signaled to by the communication chip/external device (Bodewes, [0095-0096]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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