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 .
Priority
Claims 1-6, 8-14, 17, and 19-20 are deemed to have an effective filing date of 05/11/2022. Claims 7, 15-16, and 18 are deemed to have an effective filing date of 05/10/2023 as the features of those claims are not disclosed in the provisional application (63/340,668).
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.
Claims 1, 3, 5-15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by International Publication No. WO 2021/080551 to Devarasetty et al. (hereinafter referred to as “Devarasetty”).
Referring to claim 1, Devarasetty discloses a system for monitoring a patient with a tracheostomy tube (e.g., page 1, lines 5-9: aiding in managing care of tracheostomy patients by detecting distress), the system comprising: a securement apparatus comprising a device receptacle (e.g., page 9, lines 1-30; Figs. 1A-1C, securement apparatus/band 110, device receptacle 120), wherein the securement apparatus is operable to stabilize the tracheostomy tube of the patient when the securement apparatus is secured around a neck of the patient (e.g., page 9, lines 1-30: band 110 has a passage that allows for a tracheostomy tube to pass therethrough and the passage may have alignment and/or retention features that engage with the tracheostomy tube to ensure proper alignment and positioning thereof); and a monitoring device operable to be inserted into the device receptacle of the securement apparatus, the monitoring device comprising a microcontroller and one or more sensors, the one or more sensors operable to monitor one or more physiological parameters of the patient when the monitoring device is inserted into the device receptacle of the securement apparatus (e.g., page 9, line 28-page 11, line 13: electronics including a controller and one or more sensors are inserted into device receptable 120 where the sensors monitor physiological indicators of distress; page 15, lines 20-30: monitoring device Fig. 10, microcontroller 180 receiving signals from EMG sensor 300, pulse/heart rate sensor 400 and sensor 500).
With respect to claim 3, Devarasetty discloses the system of claim 1, wherein the securement apparatus is adjustable to secure around various neck sizes, and the device receptacle of the securement apparatus is capable of positioning the one or more sensors near a carotid artery of the patient when the securement apparatus is secured around the neck of the patient (e.g., page 9, lines 11-14: band is adjustable allowing it to be placed around a plurality of differently sized necks; and the heart rate sensor 140 would be placed at the side of the neck in order to obtain the heart rate from the carotid artery of the patient).
As to claim 5, Devarasetty discloses the system of claim 1, wherein the securement apparatus is a flange extending radially from a tube body of the tracheostomy tube, wherein the flange is operable to contact the neck of a patient (e.g. page 9, lines 4-11: securement apparatus/band 110 is a flange extending radially from tracheostomy tube 20 shown in Figs. 1B-1C as installed around the neck of the patient).
With respect to claim 6, Devarasetty discloses the system of claim 1, wherein the one or more physiological parameters of the patient are at least one of temperature, heart rate, respiratory rate, blood pressure, and blood oxygen saturation (e.g., page 8, lines 18-20: heart rate).
As to claim 7, Devarasetty discloses the system of claim 1, wherein the one or more sensors is at least one of a piezoelectric sensor, an optoelectronic sensor, a photoplethysmographic sensor, an infrared sensor, a pulse oximeter, and a temperature sensor (e.g., page 5, lines 12-13: pulse sensor is an optical heart rate sensor or an optoelectronic sensor as the sensor includes electronics as well as optics; page 14, line 20-page 15, line 19: pulse circuit 400 can also be a pulse-oxygen sensor for detecting a blood oxygen content and pulse of the patient).
With respect to claim 8, Devarasetty discloses the system of claim 1, wherein the microcontroller is operable to communicate the one or more physiological parameters to a secondary device (e.g., page 15, line 20-page 16, line 2: microcontroller 180 receives physiological parameters from the sensors and communicates with a secondary device 200 via a wireless communication protocol).
As to claim 9, Devarasetty discloses the system of claim 5, wherein the microcontroller further comprises a wireless transceiver operable for wireless communication including at least one of radio frequency (RF), Wi-Fi, or Bluetooth (e.g., page 15, line 20-page 16, line 2: microcontroller 180 comprises a wireless communication chip 186 or transceiver that communication via a wireless communication protocol such as RF, Wi-Fi or Bluetooth).
With respect to claim 10, Devarasetty discloses the system of claim 1, wherein the monitoring device further comprises a rechargeable battery (e.g., monitoring device Fig. 10; and page 16, lines 6-9: power source 190 can be a rechargeable battery).
As to claims 11-12, Devarasetty discloses the system of claim 1, wherein the securement apparatus is made of an elastomer where the elastomer is silicone (e.g., page 9, lines 21-24: securement apparatus/band 110 can be made from silicone).
Regarding claim 13, Devarasetty discloses a method of monitoring a patient with a tracheostomy tube (e.g., abstract: method of monitoring physiological parameters of a patient to indicate distress of the patient; and page 1, lines 5-9: aiding in managing care of tracheostomy patients by detecting distress), the method comprising: inserting a monitoring device into a device receptacle of a tracheostomy collar (e.g., page 4, lines 15-17: attaching a distress monitor to the patient; page 5, lines 17-28: monitoring device is secured/attached within the wearable garment that secures a tracheostomy, tube and distress monitor to a neck of a patient), the monitoring device comprising a microcontroller and one or more sensors (e.g., page 9, line 28-page 11, line 13: electronics including a controller and one or more sensors are inserted into device receptable 120 where the sensors monitor physiological indicators of distress); securing the tracheostomy collar around a neck of the patient to stabilize the tracheostomy tube of the patient (e.g., page 9, lines 1-30: band 110 has a passage that allows for a tracheostomy tube to pass therethrough and the passage may have alignment and/or retention features that engage with the tracheostomy tube to ensure proper alignment and positioning thereof); monitoring, via the one or more sensors, one or more physiological parameters of the patient (e.g., page 4, lines 15-27: measuring, using the physiological sensors, changes in physiological indicators of the patient); and communicating, via the microcontroller, the one or more physiological parameters to a secondary device (e.g., page 15, line 20-page 16, line 2: microcontroller 180 receives physiological parameters from the sensors and communicates with a secondary device 200 via a wireless communication protocol).
With respect to the method of claim 14, Devarasetty discloses the method of claim 13, wherein the one or more physiological parameters are respiratory rate, blood oxygen saturation, heart rate, blood pressure and temperature (e.g., page 8, lines 18-20: heart rate).
As to claim 15, Devarasetty discloses the method of claim 13, the method further comprising providing an alarm when one or more physiological parameters exceed a threshold (e.g., page 12, lines 12-28: using the thresholding algorithm, for at least two of the three sensors being monitored to reach a threshold before triggering an alarm).
With respect to claim 17, Devarasetty discloses the method of claim 13, wherein the microcontroller communicates the one or more physiological parameters via a wireless transceiver operable for wireless communication including at least one of radio frequency (RF), Wi-Fi, or Bluetooth (e.g., page 15, line 20-page 16, line 2: microcontroller 180 comprises a wireless communication chip 186 or transceiver that communication via a wireless communication protocol such as RF, Wi-Fi___33 or Bluetooth).
As to claim 18, Devarasetty discloses the method of claim 13, wherein the one or more sensors is at least one of a piezoelectric sensor, an optoelectronic sensor, a photoplethysmographic sensor, an infrared sensor, a pulse oximeter, and a temperature sensor (e.g., page 5, lines 12-13: pulse sensor is an optical heart rate sensor or an optoelectronic sensor as the sensor includes electronics as well as optics; page 14, line 20-page 15, line 19: pulse circuit 400 can also be a pulse-oxygen sensor for detecting a blood oxygen content and pulse of the patient).
With respect to claim 19, Devarasetty discloses the method of claim 13, wherein the monitoring device comprises a rechargeable battery (e.g., monitoring device Fig. 10; and page 16, lines 6-9: power source 190 can be a rechargeable battery).
Regarding claim 20, Devarasetty discloses a tracheostomy tube comprising: a tube body (e.g., Figs. 1B-1C, tube 20); a flange extending radially from the tube body having a device receptacle (e.g. page 9, lines 4-11: flange/band 110 extends radially from tracheostomy tube 20 shown in Figs. 1B-1C as installed around the neck of the patient), wherein the flange is operable to contact a neck of a patient (e.g. page 9, lines 4-11: securement apparatus/band 110 is a flange extending radially from tracheostomy tube 20 shown in Figs. 1B-1C as installed around the neck of the patient; page 4, lines 28-30: band has an electronics region 120 or device receptacle); and a monitoring device operable to be inserted into the device receptacle, the monitoring device having a microcontroller and one or more sensors, wherein the one or more sensors are operable to monitor one or more physiological parameters of the patient (e.g., page 9, line 28-page 11, line 13: electronics including a controller and one or more sensors are inserted into device receptable 120 where the sensors monitor physiological indicators of distress; page 15, lines 20-30: monitoring device Fig. 10, microcontroller 180 receiving signals from EMG sensor 300, pulse/heart rate sensor 400 and sensor 500).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Devarasetty in view of US Patent Application Publication No. 2014/0094677 to Okuda et al. (hereinafter referred to as “Okuda”).
Devarasetty discloses the system of claim 1, wherein the securement apparatus is a collar (e.g., Fig. 1A, band 110), the collar comprising: a first section having at least one aperture; a second section having the device receptacle is located on the second
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section adjacent to the boss of the second section; and a third section having at least one aperture and at least one boss, wherein the at least one aperture of the first section is configured to removably couple to the boss of the third section (see annotated Fig. 4 and page 9, lines 11-20: band 110 has fasteners at each end that are able to secure the band around the neck of a patient, for example pins/bosses and holes). Devarasetty differs from the claimed invention in that it does not expressly disclose that the second section has a boss and that the at least one aperture of the third section is configured to removably couple to the boss of the second section.
However, Okuda, in a related art: securing of sensors to body parts, teaches that a section of the band/strap including a case 7 for holding a detection circuit board with electronics for a heart rate sensor (e.g., paragraphs [0044]-[0046] of Okuda and Fig. 2) including coupling members/bosses wherein the case is adjacent the coupling member/boss and is capable of being removably coupled to a third section (e.g., paragraph [0049] of Okuda). Accordingly, one of ordinary skill in the art would have recognized the benefits of a section of a band having both a boss and a receptacle/case for receiving electronics adjacent to one another, and removably coupling the second section to a third section of the band/strap in view of the teachings of Okuda. Consequently, one of ordinary skill in the art would have modified the band of Devarasetty so that the second section has a boss adjacent the receptable 120 and so that the third section is removably coupled to the boss of the second section as such was a known expedient for connecting an adjustable band/strap for detecting heart rate as taught by Okuda, and because the combination would have yielded a predictable result.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Devarasetty in view of US Patent Application Publication No. 2019/0232004 to Conrad.
Devarasetty discloses the system of claim 1, wherein the securement apparatus is a neck flange (e.g. page 9, lines 4-11: securement apparatus/band 110 is a flange extending radially from tracheostomy tube 20 shown in Figs. 1B-1C as installed around the neck of the patient), the neck flange comprising: a void operable to allow a proximal end of the tracheostomy tube of the patient to pass through the void in the neck flange (e.g., Figs. 1B-1C with void 112 to receive tracheostomy tube 20). Devarasetty differs from the claimed invention in that it does not expressly disclose that two apertures are each operable to receive a collar configured to secure the neck flange around the neck of the patient. However, Conrad, in a related art: tracheostomy tube-based monitoring systems and methods, teaches a flange 84 with a void for receiving an end of a tracheostomy tube 80/82, a device receptacle (monitoring device 60), two apertures/openings 88 on either side of the device receptacle, and wherein the apertures are each operable to receive a collar configured to secure the neck flange around the neck of the patient (e.g., paragraphs [0033]-[0034] and Figs. 5-6: flange 84 has openings 88 through which a band, tracheostomy tube collar, or tie can pass to secure to a patient’s neck). Accordingly, one of ordinary skill in the art would have recognized the benefits of a neck flange comprising two apertures, and a void that allows the tracheostomy tube to pass through where the two apertures are on either side of the device receptacle and are each operable to receive a collar to secure the neck flange to around the neck of the patient in view of the teachings of Conrad. Consequently, one of ordinary skill in the art would have modified the system of Devarasetty so that the securement apparatus is a neck flange comprising two apertures and a void as recited in claim 4 in view of the teachings of Conrad that such was a well-known expedient in the tracheostomy tube-based monitoring art, and because the combination would have yielded a predictable result.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Devarasetty in view of International Publication No. WO 2022/031178 to Russell et al. (hereinafter referred to as “Russell”).
Devarasetty discloses the method of claim 13, but does not expressly disclose that the method further comprises analyzing historic data from the one or more physiological parameters to determine further treatment options. The Examiner notes that Devarasetty a memory 184 in the monitoring device (Fig. 10) and pattern recognition and/or thresholding of sensed values, but does not expressly disclose analyzing saved data from the one or more physiological parameters to determine further treatment options. However, Russell, in a related art: Patient interface and respiratory support system, teaches that a closed loop control system that utilizes two control loops where a target SpO2 is input on a first loop and the output of the first control loop can be input into the SpO2 controller along with a measured SpO2 value in a second control loop to output another target value and continues as long as the therapy session lasts (e.g., paragraphs [0388]-[0389] of Russell).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2021/0146073 to Owens et al. is directed to a trachcollar safety alarm where the collar includes a sensor component and a tracheostomy tube where an alarm produces an alert (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792
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