Prosecution Insights
Last updated: April 19, 2026
Application No. 18/472,838

AUTOMATIC SHUTOFF OF GAS SUPPLY TO PATIENT WORN DEVICE

Non-Final OA §102§103
Filed
Sep 22, 2023
Examiner
JAYAN, AKHIL ADAI
Art Unit
3785
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Beaconmedaes LLC
OA Round
1 (Non-Final)
0%
Grant Probability
At Risk
1-2
OA Rounds
3y 2m
To Grant
0%
With Interview

Examiner Intelligence

Grants only 0% of cases
0%
Career Allow Rate
0 granted / 1 resolved
-70.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
25 currently pending
Career history
26
Total Applications
across all art units

Statute-Specific Performance

§101
1.6%
-38.4% vs TC avg
§103
51.6%
+11.6% vs TC avg
§102
20.3%
-19.7% vs TC avg
§112
21.9%
-18.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1 resolved cases

Office Action

§102 §103
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. Drawings The drawings are objected to because sheets 12 and 13 both disclose a Fig. 11 and a Fig. 12, where the only difference between the two sheets is the labeling of references 79a, 79b, and 79c. (Applicant may wish to consider changing the labels to read Fig. 11A, Fig. 11B, etc. with the specification correspondingly amended. ) Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “flow management device” in claims 2, 7, 12, 17, 21, and all of their dependent claims. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The corresponding structure of the “flow management device” is best understand as a device to manage, regulate, or otherwise control a flow of ga s (paragraph 00034 of specification), such as at least an electronic solenoid valve (paragraph 00026 of the specification). If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. 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. Claim s 1, 5 , 7, 9- 20 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Ellingham (US 20250161607 A1) . Regarding claim 1 , Ellingham teaches a method comprising: controlling a flow of gas ( paragraph 0010 "a controller that is operatively connected to the flow generator and operable to control a flow rate of the flow of gases" ) to a patient worn device (Fig. 1, patient interface 17) at a pressure greater or less than atmospheric pressure (paragraph 0390 “ A gauge pressure sensor may be configured to sense the gauge pressure of the flow of gases and generat e s a representative gauge pressure variable, such as a gauge pressure signal or pressure data. The gauge pressure may represent the pressure of the flow of gases in the flow path with reference or relative to atmospheric pressure ”; Any non-zero values of the sensor would indicate pressures greater or less than atmospheric pressure) ; detecting a pressure drop to atmospheric pressure (paragraph 0338 “ the leak detection algorithm may be configured to detect leaks at the outlet of the apparatus, for example detecting leaks caused by removal or disconnection (whether complete or partial) of a patient circuit (e.g. conduit or tubing) from the gases outlet of the apparatus ”; One skilled in the art would reasonably expect that the pressure drop due to the disconnection at the outlets would be a pressure drop down to atmospheric pressure) ; and in response to the detecting, automatically discontinuing the flow of the gas to the patient worn device ( paragraph 0484 "In the leak detected state 806, the algorithm may trigger one or more alarm actions, such as generating an audible, visual or tactile leak detection alarm, indicating the chamber is off or disconnected, and/or controlling or halting the flow rate or motor speed, or other control actions" ). Regarding claim 5, Ellingham teaches the method of claim 1. Ellingham further teaches wherein the automatically discontinuing of the flow of the gas ( paragraph 0484 "In the leak detected state 806, the algorithm may trigger one or more alarm actions, such as generating an audible, visual or tactile leak detection alarm, indicating the chamber is off or disconnected, and/or controlling or halting the flow rate or motor speed, or other control actions" ) to the patient includes closing a valve ( Fig. 14, valve 362 ; paragraph 0379 "The valve 362 can suitably be a solenoid valve that enables the control of the amount of oxygen that is added to the gases flow that is delivered to the humidification chamber 300" ; One skilled in the art would reasonably expect that ha lting the flow rate would involve closing the valve 362). Regarding claim 7, Ellingham teaches a method comprising: regulating, by a flow management device (Fig. 1, controller 13 and flow generator 11) of a pod (Fig. 1, main device housing 100) , a flow of gas ( paragraph 0010 "a controller that is operatively connected to the flow generator and operable to control a flow rate of the flow of gases" ) to a patient worn device (Fig. 1, patient interface 17) at a pressure greater or less than atmospheric pressure (paragraph 0390 “ A gauge pressure sensor may be configured to sense the gauge pressure of the flow of gases and generat e s a representative gauge pressure variable, such as a gauge pressure signal or pressure data. The gauge pressure may represent the pressure of the flow of gases in the flow path with reference or relative to atmospheric pressure ”; Any non-zero values of the sensor would indicate pressures greater or less than atmospheric pressure), the pod configured to receive an accessory (Fig. 2, humification chamber 300; paragraph 0366 “ The peripheral wall arrangement defines a humidifier or humidification chamber bay 108 for receipt of a removable humidification chamber 300 ”) having an outlet (paragraph 0377 “ humidification chamber gases outlet port 308 ”; Fig. 3) and a pressure sensor (paragraph 0359 “ The sensors 3a, 3b, 3c, 20, 25, such as pressure, temperature, humidity, and/or flow sensors, can be placed in various locations in the main device housing 100, the patient conduit 16, and/or the patient interface 17 ”) disposed proximate the outlet of the accessory (Fig. 1 shows sensor 3b proximate to the outlet of the humidifier 12) ; receiving, by a control interface of the pod (Fig. 1, see the line connecting controller 13 to 12) , a signal from the pressure sensor of the accessory indicating that the pressure has dropped to atmospheric pressure (paragraph 0477 “ the algorithm 800 receives a pressure variable representing the pressure signal or data sensed by a gauge pressure sensor that is configured to sense the gauge pressure of the flow of gases in the flow path ” where gauge pressure sensor could be sensor 3b; paragraph 0480 “ the gauge pressure variable is compared to definite and possible leak thresholds to determine the leak state of the apparatus, e.g. leak detected, possible leak, or no leak ”; paragraph 0338 “ the leak detection algorithm may be configured to detect leaks at the outlet of the apparatus, for example detecting leaks caused by removal or disconnection (whether complete or partial) of a patient circuit (e.g. conduit or tubing) from the gases outlet of the apparatus ” One skilled in the art would reasonably expect that if a tube is disconnected, this would alter the pressure levels to atmospheric pressure, which would be measured be pressure sensor 3b) ; and transmitting, by the control interface of the pod (paragraph 0414 “ The leak detection process or method 700 in this example is implemented as an algorithm executed by a processor or controller of the apparatus ”) , a control signal to the flow management device to stop the flow of gas to the patient worn device (paragraph 0484 “ In the leak detected state 806, the algorithm may trigger one or more alarm actions, such as generating an audible, visual or tactile leak detection alarm, indicating the chamber is off or disconnected, and/or controlling or halting the flow rate or motor speed ”) . Regarding claim 9, Ellingham teaches the method of claim 7. Ellingham further teaches wherein the pressure drop is caused by a disconnection of a fluidic connection between the flow management device and the patient worn device ( paragraph 0418 "it will be appreciated that the principles of operation of the leak detection algorithm may be applied to detect other types of leaks along the flow path, or leaks at the outlet of the flow path of the apparatus such as those caused by partial or complete disconnection of the patient conduit or tubing of a patient circuit from the gases outlet of the apparatus" ). Regarding claim 10, Ellingham teaches the method of claim 9. Ellingham further teaches wherein the fluidic connection is established by tubing connected at a first end to the outlet of the accessory and at a second end to the patient worn device (Fig. 1 shows breathing conduit 16 connected between the outlet of humidifier 12 at one end and patient interface 17 at the other end; paragraph 0350 "The gases flow can be generated by the flow generator 11, and may be humidified, before being delivered to the patient via the patient breathing conduit 16 through the patient interface 17" ). Regarding claim 11, Ellingham teaches the method of claim 9. Ellingham further teaches wherein the disconnection is a result of the first end of a tubing being removed from the outlet of the accessory (paragraph 0418 discusses leak detection being applied when the patient conduit or tubing is disconnected from the gas outlets of the apparatus). Regarding claim 12 , Ellingham teaches a removable accessory (Fig. 1, humidifier 12; paragraph 0089 “ a humidifier that is operable to heat and humidify the flow of gases, the humidifier comprising a removable humidification chamber in the flow path ”) for use with a pod (Fig. 1, main device housing 100) , the removable accessory comprising: a body portion having a first side (Fig. 3, where there is a top side of 300 facing up from pod 100) and a second side (Fig. 3, where there is another side facing towards the pod 100 that comprises ports 306 and 308) ; at least one fluidic coupling disposed on the body portion (Fig. 3, port 306) configured to be fluidically coupled to a flow management device of the pod (paragraph 0376 “ The gases outlet port 322, gases inlet port 340, and patient outlet port 344 each can have soft seals such as O-ring seals or T-seals to provide a sealed gases passageway between the apparatus 10, the humidification chamber 300, and the patient conduit 16 ”; paragraph 0377 “ The humidification chamber gases inlet port 306 can be complementary with the gases outlet port 322 ”; the apparatus 10 has flow management components controller 13 and flow generator 11) , as a function of the removable accessory being inserted within a pod casing of the pod (paragraph 0375 “ The humidification chamber 300 can be fluidly coupled to the apparatus 10 in a linear slide-on motion in a rearward direction of the humidification chamber 300 into the chamber bay 108 ”) ; an outlet (Fig. 3, outlet 308) fluidically connected to the at least one fluidic coupling (paragraph 0376 “ The gases outlet port 322, gases inlet port 340, and patient outlet port 344 each can have soft seals such as O-ring seals or T-seals to provide a sealed gases passageway between the apparatus 10, the humidification chamber 300, and the patient conduit 16 ”; Fig. 3 shows outlet 308 connected to gases inlet port 340 , and paragraph 0376 teaches a gas passageway built from ports 322, 340, and 344, which means that 308 is fluidically connected to 306 via this passageway) disposed on the body portion (Fig. 3 shows 308 on the body portion of 300) and configured to be attached to a tubing that fluidically connects the removable accessory to a patient worn device (outlet port 308 fluidly connected to gases inlet port 340 fluidly connected to patient outlet port 344 which is fluidly connected to patient conduit 16, see paragraph 0376; patient conduit 16 to patient interface 17 as shown in Fig. 1) ; and a sensor (Fig. 1, sensor 3b) disposed proximate the outlet (Fig. 1, 3b is proximate to the outlet of the humidifier) and configured to detect a pressure differential within the body portion of the accessory (see paragraph 0390 which teaches a gauge pressure sensor that could represent a pressure difference between pressure in the flow path and housing; One skilled in the art would reasonably expect that the gauge pressure sensor 3b would measure a pressure difference between the flow path and body portion of 300). Regarding claim 13 , Ellingham teaches the accessory of claim 12. Ellingham further teaches w herein the sensor transmits a signal (paragraph 0390 “ A gauge pressure sensor may be configured to sense the gauge pressure of the flow of gases and generates a representative gauge pressure variable, such as a gauge pressure signal or pressure data ”) to the pod (paragraph 0395 “ the leak detection algorithm may be configured to receive a gauge pressure signal or data from a gauge pressure sensor representing the gauge pressure associated with the flow of gases in the flow path ”; paragraph 0414 “ The leak detection process or method 700 in this example is implemented as an algorithm executed by a processor or controller of the apparatus ”; the pressure signal is transmitted to the leak algorithm which is part of the controller 13 within pod 100 as shown in Fig. 1) to discontinue a flow of gas to the patient worn device (paragraph 0484 “I n the leak detected state 806, the algorithm may trigger one or more alarm actions, such as generating an audible, visual or tactile leak detection alarm, indicating the chamber is off or disconnected, and/or controlling or halting the flow rate ”) if the pressure differential indicates a pressure proximate the outlet (sensor 3b is proximate to outlet of humidifier 12 in Fig. 1) is at or near atmospheric pressure (paragraph 0338 “ the leak detection algorithm may be configured to detect leaks at the outlet of the apparatus, for example detecting leaks caused by removal or disconnection (whether complete or partial) of a patient circuit (e.g. conduit or tubing) from the gases outlet of the apparatus ”; One skilled in the art would reasonably expect that if a tube is disconnected, this would alter the pressure levels to atmospheric pressure, which would be measured be pressure sensor 3b). Regarding claim 14, Ellingham teaches the accessory of claim 13. Ellingham further teaches wherein the sensor is on the accessory (Fig. 1, sensor 3b is shown on humidifier 12). Ellingham does not specifically teach wherein the sensor is integrated within the body portion of the accessory. However, the product disclosed by the prior art is identical to the claimed product, even though it is made differently. The position of the sensor 3b on accessory 12 in the prior art is not patentably distinct from the integrated sensor in the claimed product. There is no evidence to show that the claimed integration of the sensor imparts any patentable distinction between the claimed product and that of the prior art. See I n re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 . See also MPEP § 21 44. Regarding claim 15 , Ellingham teaches the accessory of claim 12. Ellingham further teaches wherein the sensor is in fluidic communication with the tubing attached to the outlet (paragraph 0392 “ the one or more pressure sensors that are configured to sense or measure a pressure characteristic of the flow of gases may be directly in or at least partially immersed in the main or bulk flow path of the flow of gases [ e.g. the sensors may be part of or exposed to a sensor passage or sensor chamber that forms part of the main or bulk flow path ]; One skilled in the art would reasonably expect that sensor 3b would be in fluid communication with the gas path through the outlet of the humidifier 12 in Fig. 1 that couples to patient conduit 16). Regarding claim 1 6 , Ellingham teaches the accessory of claim 12. Ellingham further teaches the accessory comprising a canister operably attached to the body portion (Fig. 3 wherein the curved side and back portions of chamber 300 form a canister shape) , wherein the canister contains a liquid for humidifying a fluid passing through the removable accessory (paragraph 0366 “ The removable humidification chamber 300 contains a suitable liquid such as water for humidifying gases that can be delivered to a patient ”). Regarding claim 17, Ellingham teaches a system comprising: a pod (Fig. 1, main device housing 100) comprising a flow management device (Fig. 1, flow generator 11) disposed within a pod casing (paragraph 0348 “ The main device housing 100 can contain a flow generator 11 that can be in the form of a motor/impeller arrangement, a humidifier 12, a controller 13, and a user interface 14 ”; paragraph 0366 “ The main housing 100 has a main housing upper chassis 102 and a main housing lower chassis 202 ” where the upper and lower chassis are a pod casing), at least one fluidic coupling within the casing that is fluidically connected to the flow management device (Fig. 3, gases outlet port 322; paragraph 0375 “ A gases outlet port 322 can be in fluid communication with the motor ” where the motor is part of the flow management device) ; a removable accessory for use with the pod (paragraph 0366 “ The removable humidification chamber 300 ”) , the removable accessory comprising : a body portion having a first side and a second side ( Fig. 3, where there is a top side of 300 facing up from pod 10 0 another side facing towards the pod 100 that comprises ports 306 and 308 ) , at least one fluidic coupling disposed on the body portion (F ig. 3, port 306 ) that fluidically connects with the at least one fluidic coupling ( paragraph 0377 “The humidification chamber gases inlet port 306 can be complementary with the gases outlet port 322” ) within the casing of the pod as a function of the removable accessory being inserted into the pod ( paragraph 0375 “The humidification chamber 300 can be fluidly coupled to the apparatus 10 in a linear slide-on motion in a rearward direction of the humidification chamber 300 into the chamber bay 108” ) , and an outlet (Fig. 3, outlet 308) ; a sensor (Fig. 1, sensor 3b) configured to detect a change in pressure (paragraph 0359 teaches sensor 3b can be a pressure sensor) at the outlet of the removable accessory ( Fig. 1, 3b is proximate to the outlet of the humidifier ) ; and a control interface (Fig. 1 controller 13) electrically connected to the sensor (paragraph 0360 “ The apparatus 10 can include a wireless data transmitter and/or receiver, or a transceiver 15 to enable the controller 13 to receive data signals 8 in a wireless manner from the operation sensors and/or to control the various components of the system 10 ”) and configured to receive a signal from the sensor indicating the change in pressure (paragraph 0359 “ The controller 13 can receive output from the sensors to assist it in operating the respiratory apparatus 10 in a manner that provides suitable therapy, such as to determine a suitable target temperature, flow rate, and/or pressure of the gases flow ”), wherein the control interface sends a control signal to the flow management device to stop a gas from flowing (paragraph 0484 “ the algorithm may trigger one or more alarm actions, such as generating an audible, visual or tactile leak detection alarm, indicating the chamber is off or disconnected, and/or controlling or halting the flow rate or motor speed ”) through the outlet to a patient worn device (paragraph 0376 “ The gases outlet port 322, gases inlet port 340, and patient outlet port 344 each can have soft seals such as O-ring seals or T-seals to provide a sealed gases passageway between the apparatus 10, the humidification chamber 300, and the patient conduit 16 ”; the humidification chamber 300, apparatus 10, and patient conduit 16 all form gas passageway between each other, therefore halting the flow rate would stop gas flow in the outlet 308 and in patient conduit 16 which connects to a patient worn device 17). Regarding claim 18, Ellingham teaches the system of claim 17. Ellingham further teaches comprising a tubing (Fig. 1, patient conduit 16) connected at a first end to the outlet of the removable accessory (paragraph 0377 “ the humidification chamber gases outlet port 308 can be complementary with the gases inlet port 340 ”; paragraph 0376 “ A gases inlet port 340 (humidified gases return) as shown in FIG. 8 can include a removable L-shaped elbow or ‘elbow conduit’ generally indicated at 320. The removable elbow can further include a patient outlet port 344 for coupling to the patient conduit 16 to deliver gases to the patient interface ”) and at a second end to the patient worn device (Fig. 1, conduit 16 connected to patient worn device 17) , so that the gas delivered to the patient worn device flows from the outlet to the patient worn device when the tubing is connected at both the first end and the second end of the tubing (paragraph 0376 “ The removable elbow can further include a patient outlet port 344 for coupling to the patient conduit 16 to deliver gases to the patient interface. The gases outlet port 322, gases inlet port 340, and patient outlet port 344 each can have soft seals such as O-ring seals or T-seals to provide a sealed gases passageway between the apparatus 10, the humidification chamber 300, and the patient conduit 16 ”). Regarding claim 19, Ellingham teaches the system of claim 17. Ellingham further teaches wherein the change in pressure reflects a pressure drop to atmospheric pressure at the outlet as a result of the patient worn device being fluidically disconnected from the outlet (paragraph 0338 “ the leak detection algorithm may be configured to detect leaks at the outlet of the apparatus, for example detecting leaks caused by removal or disconnection (whether complete or partial) of a patient circuit (e.g. conduit or tubing) from the gases outlet of the apparatus ”; One skilled in the art would reasonably expect that if a patient worn device is disconnected, this would alter the pressure levels to atmospheric pressure, which would be measured be pressure sensor 3b at the outlet). Regarding claim 20, Ellingham teaches the system of claim 17. Ellingham further teaches wherein the change in pressure reflects a pressure drop to atmospheric pressure at the outlet as a result of the tubing being removed from the outlet (paragraph 0338 “ the leak detection algorithm may be configured to detect leaks at the outlet of the apparatus, for example detecting leaks caused by removal or disconnection (whether complete or partial) of a patient circuit (e.g. conduit or tubing) from the gases outlet of the apparatus ”; One skilled in the art would reasonably expect that if a tubing is disconnected, this would alter the pressure levels to atmospheric pressure, which would be measured be pressure sensor 3b at the outlet). 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claims 2-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ellingham (US 20250161607 A1) in view of Jafari (US 8746248 B2). Regarding claim 2 , Ellingham teaches the method of claim 1. Ellingham further teaches wherein a flow management device (Fig. 1, flow generator 11 and controller 13) of an oxygen therapy device (paragraph 0379 “ The device can have the arrangement shown in FIGS. 11 to 14 to enable the blower to deliver air, oxygen (or alternative auxiliary gas), or a suitable mixture thereof to the humidification chamber 300 and thereby to the patient ”) controls the flow to the patient worn device ( paragraph 0348 "The controller 13 can include one or more hardware and/or software processors and can be configured or programmed to control the components of the system, including but not limited to operating the flow generator 11 to create a flow of gases for delivery to a patient" ), and a fluidic connection is established by tubing connected at a first end to the flow management device and at a second end to the patient worn device ( paragraph 0350 "The gases flow can be generated by the flow generator 11, and may be humidified, before being delivered to the patient via the patient breathing conduit 16 through the patient interface 17" ). Ellingham is silent wherein in the device is a suction and oxygen therapy device. However, Jafari teaches a suction and oxygen therapy device ( Fig. 1, expiratory module 40 ; column 3 lines 38-40 “ pneumatic system 22 [ also referred to as a pressure generating system 22 ] for circulating breathing gases to and from patient 24 ”; One skilled in the art would reasonably expect that circulating gases from the patient with the expiratory module 40 requires drawing out air from patient; column 4, lines 1-2 “ The pneumatic system may include a variety of other components, including sources for pressurized air and/or oxygen ” ) with a flow management device (Fig. 1, controller 50 and pneumatic system 22) that controls the flow to a patient worn device (column 4 lines 38-40 “ controller 50 issues commands to pneumatic system 22 in order to control the breathing assistance provided to the patient by the ventilator ”), and a fluidic connection established by tubing connected at a first end to the flow management device (Fig. 1, left end of ventilation tubing system 26 connected to 22) and at a second end to a patient worn device (Fig. 1, right end of tubing system 26 connected to patient interface 28). Thus, 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 the product of Ellingham to include suction therapy . This allows the device to control both inspiration and expiration of the gas flow to a patient and to provide the benefits of suction therapy to a patient. Regarding claim 3, modified Ellingham teaches the method of claim 2. Ellingham further teaches wherein the pressure drop is caused by a disconnection of the fluidic connection between the flow management device and the patient worn device ( paragraph 0418 "it will be appreciated that the principles of operation of the leak detection algorithm may be applied to detect other types of leaks along the flow path, or leaks at the outlet of the flow path of the apparatus such as those caused by partial or complete disconnection of the patient conduit or tubing of a patient circuit from the gases outlet of the apparatus" ). Regarding claim 4, modified Ellingham teaches the method of claim 3. Ellingham further teaches wherein the disconnection is a result of the first end of the tubing being removed from an outlet of the flow management device (paragraph 0418 discusses leak detection being applied when the patient conduit or tubing is disconnected from the gas outlets of the apparatus). Regarding claim 6, modified Ellingham teaches the method of claim 3. Ellingham further teaches wherein the disconnection is a result of the second end of the tubing being removed from the patient worn device ( paragraph 0418 " Other leaks that may be detected could include partial or complete disconnection of connections or couplings or conduits forming or defining the flow path within the apparatus, or leaks caused by holes or ruptures in along the flow path of the apparatus or patient circuit conduit or tubing" ; One skilled in the art would reasonably expect that the disconnection of between tubing 16 and patient worn device 17 would be considered a hole or rupture along the patient circuit conduit or tubing). Claim s 8 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ellingham (US 20250161607 A1). Regarding claim 8, Ellingham teaches the method of claim 7. Ellingham further teaches a valve of the flow management device (paragraph 0379 “ The valve 362 can suitably be a solenoid valve that enables the control of the amount of oxygen that is added to the gases flow that is delivered to the humidification chamber 300 ”). Ellingham does not specifically teach closing the valve as a function of the control signal . However, Ellingham does teach stopping the function of the apparatus and flow generator as a function of the leak algorithm (paragraph 0484 “ the algorithm may trigger one or more alarm actions, such as generating an audible, visual or tactile leak detection alarm, indicating the chamber is off or disconnected, and/or controlling or halting the flow rate or motor speed ” ) and the valve controlling the amount of oxygen added to the gas flow (paragraph 0379 “ The valve 362 can suitably be a solenoid valve that enables the control of the amount of oxygen that is added to the gases flow that is delivered to the humidification chamber 300 ”). Thus, 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 the product of Ellingham to include closing the valve as part of halting the flow rate . This cuts off the oxygen flow and preserves the oxygen supply that flows into the system through the valve. Regarding claim 21, Ellingham teaches a pod ( Fig. 1, main device housing 100) comprising: a flow management device (Fig. 1, flow generator 11) disposed within a pod casing ( paragraph 0348 “The main device housing 100 can contain a flow generator 11 that can be in the form of a motor/impeller arrangement, a humidifier 12, a controller 13, and a user interface 14”; paragraph 0366 “The main housing 100 has a main housing upper chassis 102 and a main housing lower chassis 202” where the upper and lower chassis are a pod casing ) , the flow management device electrically coupled to a control interface (paragraph 0348 “ The controller 13 can include one or more hardware and/or software processors and can be configured or programmed to control the components of the system, including but not limited to operating the flow generator 11 to create a flow of gases for delivery to a patient ”); at least one fluidic coupling within the casing that is fluidically connected to the flow management device ( Fig. 3, gases outlet port 322; paragraph 0375 “A gases outlet port 322 can be in fluid communication with the motor” where the motor is part of the flow management device ) , the at least one fluidic coupling configured to fluidically connect (paragraph 0376 “ The gases outlet port 322, gases inlet port 340, and patient outlet port 344 each can have soft seals such as O-ring seals or T-seals to provide a sealed gases passageway between the apparatus 10, the humidification chamber 300, and the patient conduit 16 ”) with a removable accessory ( paragraph 0366 “The removable humidification chamber 300” ) insertable within the pod casing (Fig. 15; paragraph 0366 “ The peripheral wall arrangement defines a humidifier or humidification chamber bay 108 for receipt of a removable humidification chamber 300 ”); a pressure sensor of the removable accessory (Fig. 1, sensor 3b on the humidifier 12; paragraph 0359 “ The sensors 3a, 3b, 3c, 20, 25, such as pressure, temperature, humidity, and/or flow sensor ”) . Ellingham is silent on a receptacle within the casing that is configured mate with a pressure sensor of the removable accessory , the receptacle electrically coupled to the control interface so that when the removable accessory is inserted within the pod casing, data from the pressure sensor is received by the control interface . However, Ellingham does teach a receptable (Fig. 14, connector arrangement 274) within the casing (Fig. 14, 274 is on the main device housing 100), the receptacle electrically coupled to the control interface (paragraph 0380 “ Components of the electronics boards [ such as but not limited to one or more microprocessors ] can act as the controller 13 of the apparatus ”; paragraph 0382 “ The electronics boards can be in electrical communication with a connector arrangement 274 projecting from the rear wall 122 of the upper housing chassis 102 ”). Ellingham also teaches using wired connections between the sensors and controller (paragraph 0360 “ The system 10 can include a wired connection, for example, using cables or wires, to enable the controller 13 to receive data signals 8 from the operation sensors and/or to control the various components of the apparatus 10 ”). Thus, 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 the product of Ellingham to apply the connector arrangement to the area where the humidifier attaches to the pod to provide a more secure and reliable wired connection between sensor 3b and the controller 13. In this modification, when connector arrangement 274 connects with the wired connection of sensor 3b when humidifier 12 is inserted within the pod casing, this connection allows data from sensor 3b to be received by controller 13. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yamanaka ( US 20220152335 A1 ) teaches a removable main unit 20 which is an accessory to base unit 40 and comprises outlets and a pressure sensor. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT AKHIL A JAYAN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-6099 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 8am-5pm . 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, FILLIN "SPE Name?" \* MERGEFORMAT Kendra Carter can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 5712729034 . 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. /AKHIL A JAYAN/ Examiner, Art Unit 3785 /JOSEPH D. BOECKER/ Primary Examiner, Art Unit 3785
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Prosecution Timeline

Sep 22, 2023
Application Filed
Mar 05, 2026
Non-Final Rejection — §102, §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
0%
Grant Probability
0%
With Interview (+0.0%)
3y 2m
Median Time to Grant
Low
PTA Risk
Based on 1 resolved cases by this examiner. Grant probability derived from career allow rate.

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