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 .
Response to Amendment
The amendments filed 8/20/2026 have been entered. Accordingly, claims 82-88, 90-102 are pending in the current application. The amendments have overcome the 112b rejections previously set forth in the non-final office action dated 4/27/2026. The Examiner notes a new 112b rejected is being applied for newly added claim 102.
Response to Arguments
Applicant’s arguments with respect to claim(s) 82-88, 90-102 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The Examiner notes that while the same prior art is being applied, a new mapping/interpretation is now being applied to reflect the newly added limitations.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 102 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 102 recites the interface has only three terminals corresponding to the first power line, second power and data line. However, claim 82 has been amended to recite an analog sensor line, along with the first and second power lines, and data line, and therefore the interface has at least four corresponding terminals.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 82-88, 91-92, 96-100, and 102 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu (WO 2017/043981 A1).
Regarding claim 82, Liu discloses a respiratory or surgical humidifier comprising (respiratory humidification system 100, Abstract and Figure 1): a heater base configured to receive a humidifier chamber (base 108 comprising heater plate 120 configured to receive a humidification chamber 114, Figure 1 and Paragraph 0093) and supply humidified gases to a breathing tube when coupled with the humidifier chamber (breathing circuit tube 200, Paragraph 0096 and Figure 1), the heater base comprising a control circuit (the heater plate 120 can be controlled through a controller 122, Figure 1 and Paragraph 0185); and an electrical connector for electrically coupling the control circuit to the breathing tube (an intermediate electrical connector 214 can be configured to electrically couple elements of the first and second segments 202a/202b of the breathing tube, Paragraphs 0102 and 0109 and Figures 1-2), wherein the electrical connector comprises an interface configured to electrically connect to the breathing tube (the structure 216 at complementary ends of the first and second segments 202a/b of the breathing tube are configured to house the electrical connector 214, thereby comprising an interface to which the components are electrically connected, Paragraph 0106 and Figure 2), the electrical connector comprising: a first power line (the intermediate connector 214 can be configured to allow a single controller to control power to the heater wires 206a, 206b, Paragraph 0109 and Figures 1-2) running from the heater base to the interface (see heater wires 206a/b running from the heater plater 120 to the interface at which the connector 214 and structure 216 are coupled, Figures 1-2); a second power line (second heater wire 206b, Paragraph 0109); running from the heater base to the interface (see heater wires 206a/b running from the heater plater 120 to the interface at which the connector 214 and structure 216 are coupled, Figures 1-2); an analog sensor line (an analog signal from thermistors 204a,b can be sent to the humidifier controller 122 on a single data line, Paragraph 0183 and Figures 10-11); a ground line (ground line wire 702, 704, Paragraph 0176 and Figure 7); an analog sensor between the analog sensor line and the ground line (see control circuitry diagram as shown in Figure 10, wherein the thermistor 204a is between the thermistor data line and a ground line); one or more digital devices, wherein at least one of the one or more digital devices comprises a sensor (system may include a digital temperature sensor, Paragraph 0103); and a data line configured to allow serial communication between the control circuit and one or more digital devices (data line can be used to allow communication between a microcontroller and the humidifier controller 122 to provide temperature data from the digital temperature sensors, Paragraphs 0103 and 0183 and Figure 10); wherein the one or more digital devices are configured to be parasitically powered and to receive electrical energy over the data line (the digital sensors may utilize a single line for communication and power, therefore receiving electrically energy over the data line, Paragraph 0187 and Figure 13).
Regarding claim 83, Liu further discloses wherein the one or more digital devices comprises a sensor configured to sense an ambient temperature (system may include a digital temperature sensor, Paragraph 0103).
Regarding claim 84, Liu further discloses wherein the analog sensor is configured to sense an ambient temperature (the microcontroller can be used to measure an analog signal from the thermistors 204a and 204b and convert the analog signal into a digital signal using analog-to-digital converters (ADCs), the converted digital signal can be sent to the humidifier controller 122 on a single data line, Paragraph 0183 and Figure 10).
Regarding claim 85, Liu further discloses wherein the electrical connector comprises a first end, a second end, and a housing intermediate the first end and the second end (see connector 214 comprising a first and second end, with an intermediate housing 263, Figures 14C-14D and Paragraph 0191), wherein the one or more digital devices is located in the housing (microcontroller disposed within connector 214, Figure 10), wherein the analog temperature sensors is located in the housing (thermistor sensors 204a disposed in connector 214 housing, Paragraph 0119 and Figure 10), and wherein the one or more digital temperature sensors and the one or more analog temperature sensors are provided on a common printed circuit board (PCB) in the housing (temperature sensors and associated circuitry provided on the intermediate PCB 250 of the connector 214, Paragraph 0188 and Figures 14A-B).
Regarding claim 86, Lui further discloses wherein the control circuit is configured to determine ambient temperature using an output from the one or more digital sensors and an output from the one or more analog temperature sensors, and wherein the control circuit is configured to control an amount of power delivered to the breathing tube over the power lines based on the determined ambient temperature (control algorithms may use temperature readings determined from the temperature sensors to directly control the duty cycle of the heater to a tailored value, Paragraph 0141). The Examiner notes the 112b rejection presented above for this particular limitation.
Regarding claim 87, Liu further discloses wherein the control circuit is configured to detect a fault when an output of the one or more digital sensors or a value derived from the output of the one or more digital sensors differs from an output of the one or more analog sensors or a value derived from the output of the one or more analog sensors by an amount greater than a first difference threshold for a period greater than a first time threshold (When a difference between an output of the sensor and a patient end parameter set point is below a predetermined error threshold, the processor can be configured to heat the respiratory gases using the first heater circuit until a maximum temperature is reached in the first heater wire, Paragraph 0012; see also Paragraph 0103 describing the output of sensors 204a/204b being sent to the controller 122 as feedback for use in controlling power to the heating elements).
Regarding claim 88, Liu further discloses wherein the control circuit is configured to detect a fault when an output of the one or more digital sensors or a value derived from the output of the one or more digital sensors differs from an output of the one or more analog sensors or a value derived from the output of the one or more analog sensors by an amount greater than a second difference threshold for a period greater than a second time threshold (When a difference between an output of the sensor and a patient end parameter set point is below a predetermined error threshold, the processor can be configured to heat the respiratory gases using the first heater circuit until a maximum temperature is reached in the first heater wire, Paragraph 0012; see also Paragraph 0103 describing the output of sensors 204a/204b being sent to the controller 122 as feedback for use in controlling power to the heating elements).
Regarding claim 91, Liu further discloses wherein the control circuit and the one or more digital devices are configured to communicate using a 1-wire communication protocol (single data line used for communication between microcontroller and the humidifier controller, Paragraph 0183 and Figure 10).
Regarding claim 92, Liu further discloses wherein the one or more digital devices are located in the humidifier chamber, the breathing tube, in an intermediate tube section between the humidifier chamber and the breathing tube or between the breathing tube and a patient interface (microcontroller is disposed in the electric connector 214 which is disposed between the patient end and the humidifier chamber, Figures 2 and 9).
Regarding claim 96, Liu further discloses a component configured to be electrically connected to the electrical connector (heater wires 206a/206b electrically connected with connector 214, Paragraph 0111 and Figure 2), the component comprising: a first power line configured to be electrically connected to the first power line of the electrical connector (first heater wire 206a coupled to connector 214 at connection points 226, Paragraph 0110 and Figure 2); a second power line configured to be electrically connected to the second power line of the electrical connector (second heater wire 206b coupled to connector 214 at connection points 226, Paragraph 0110 and Figure 2); and a data line configured to be electrically connected to the data line of the electrical connector (data line communication, Paragraph 0183 and Figure 2); wherein the second power line of the component is configured to provide a reference for communications on the data line of the component (signals from the thermistors 204a and 204b used for control of humidifier, Paragraph 0183); and wherein the component is a breathing tube, an intermediate component of a breathing circuit (wires are an intermediate component of the breathing circuit as shown in Figure 2), a humidifier chamber, or an intermediate connector.
Regarding claim 97, Liu discloses a respiratory or surgical humidifier system (respiratory humidification system 100, Abstract and Figure 1) comprising: a respiratory or surgical humidifier comprising a control circuit (base 108 the heater plate 120 can be controlled through a controller 122, Figure 1 and Paragraph 0185); and an electrical connector for electrically coupling the control circuit to a breathing tube (an intermediate electrical connector 214 can be configured to electrically couple elements of the first and second segments 202a/202b of the breathing tube, Paragraphs 0102 and 0109 and Figures 1-2), the electrical connector comprising: an analog temperature sensor (an analog signal from thermistors 204a,b can be sent to the humidifier controller 122 on a single data line, Paragraph 0183 and Figures 10-11) a data line (data line can be used to allow communication between a microcontroller and the humidifier controller 122 to provide temperature data, the microcontroller being the one or more digital device, Paragraph 0183 and Figure 10); and one or more digital devices configured to perform serial communication with the control circuit over the data line (data line can be used to allow communication between a microcontroller and the humidifier controller 122 to provide temperature data, the microcontroller being the one or more digital device, Paragraph 0183 and Figure 10); the one or more digital devices, wherein at least one of the one or more digital devices comprises a sensor (system may include a digital temperature sensor, Paragraph 0103) wherein the one or more digital devices are configured to be parasitically powered and to receive electrical energy over the data line (the digital sensors may utilize a single line for communication and power, therefore receiving electrically energy over the data line, Paragraph 0187 and Figure 13).
Regarding claim 98, Liu further discloses wherein the one or more digital devices are located in the humidifier chamber, the breathing tube, and/or in an intermediate tube section between the humidifier chamber and the breathing tube or between the breathing tube and a patient interface (microcontroller is disposed in the electric connector 214 which is disposed between the patient end and the humidifier chamber, Figures 2 and 9).
Regarding claim 99, Liu further discloses a component configured to be electrically connected to the electrical connector (heater wires 206a/206b electrically connected with connector 214, Paragraph 0111 and Figure 2), the component comprising: a first power line configured to be electrically connected to the first power line of the electrical connector (first heater wire 206a coupled to connector 214 at connection points 226, Paragraph 0110 and Figure 2); a second power line configured to be electrically connected to the second power line of the electrical connector (second heater wire 206b coupled to connector 214 at connection points 226, Paragraph 0110 and Figure 2); and a data line configured to be electrically connected to the data line of the electrical connector (data line communication, Paragraph 0183 and Figure 2); wherein the second power line of the component is configured to provide a reference for communications on the data line of the component (signals from the thermistors 204a and 204b used for control of humidifier, Paragraph 0183); and wherein the component is a breathing tube, an intermediate component of a breathing circuit (wires are an intermediate component of the breathing circuit as shown in Figure 2), a humidifier chamber, or an intermediate connector.
Regarding claim 100, Liu discloses an electrical connector for a respiratory or surgical humidifier (an intermediate electrical connector 214 can be configured to electrically couple elements of the first and second segments 202a/202b of the breathing tube, Paragraphs 0102 and 0109 and Figures 1-2), characterized in that the electrical connector comprising : an analog temperature sensor (an analog signal from thermistors 204a,b can be sent to the humidifier controller 122 on a single data line, Paragraph 0183 and Figures 10-11) a data line (data line can be used to allow communication between a microcontroller and the humidifier controller 122 to provide temperature data, the microcontroller being the one or more digital device, Paragraph 0183 and Figure 10); a digital device electrically connected to the data line and configured to perform serial communications over the data line (data line can be used to allow communication between a microcontroller and the humidifier controller 122 to provide temperature data, the microcontroller being the one or more digital device, Paragraph 0183 and Figure 10); the digital device comprises a temperature sensor (system may include a digital temperature sensor, Paragraph 0103) wherein the one or more digital devices are configured to be parasitically powered and to receive electrical energy over the data line (the digital sensors may utilize a single line for communication and power, therefore receiving electrically energy over the data line, Paragraph 0187 and Figure 13) a first releasable end connector configured to electrically connect to a breathing tube (connection points 226 configured to electrically connect to the breathing tube 202b, Figure 2 and Paragraph 0110); and a second releasable end connector configured to electrically connect to a respiratory or surgical humidifier (connection points 226 configured to electrically connect to a humidifier chamber, Figure 2 and Paragraph 0110).
Regarding claim 102, Liu further discloses wherein the interface has only three terminals, each of the terminals provided on a respective one of the first power line, the second power line, and the data line (The Examiner notes the 112b rejection presented above, however also notes Liu’s electrical connector 214 has three corresponding terminals for the first and second power line, and data line, Figures 1-2).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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(s) 90 are rejected under 35 U.S.C. 103 as being unpatentable over Liu (WO 2017/043981 A1) in view of Makinson et al. (US 2006/0237014 A1).
Regarding claim 90, Liu teaches the respiratory or surgical humidifier of claim 82, however is silent wherein the one or more digital devices that are parasitically powered are configured to receive electrical energy over the data line, and wherein the control circuit and the one or more digital devices are configured to communicate on the data line wherein the data line acts as a bus
However, Makinson teaches a breathing assistance apparatus (Abstract and Figure 1) configured to communicate with one or more digital devices (microcontroller 600, Paragraph 0069 and Figure 6), wherein the one or more digital devices is configured to be parasitically powered (power to operate the microcontroller 600 comes from a parasitic power source 604, Paragraph 0069 and Figure 6) further teaching wherein the one or more digital devices that are parasitically powered are configured to receive electrical energy over the data line, and wherein the control circuit and the one or more digital devices are configured to communicate on the data line wherein the data line acts as a bus (power to operate the microcontroller 600 comes from a parasitic power source 604, the power supply is called this because it extracts the power required from the same serial port interface that is used for communications, such that power is extracted from the transmit line 606, the transmit line 606 and receive line 608 are connected to a serial port shown generally as 610, Paragraph 0069 and Figure 6).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Liu’s device such that the one or more digital devices (microcontroller) is configured to be parasitically powered such that it receives energy over a data line, as taught by Makinson, as powering a microcontroller parasitically offers various benefits such as reduced wiring and connectivity, removal of external power components such as batteries, therefore reducing overall manufacturing costs.
Claim 93 is rejected under 35 U.S.C. 103 as being unpatentable over Liu (WO 2017/043981 A1) in view of Panarello et al. (US 2019/0117919 A1).
Regarding claim 93, Liu teaches the respiratory or surgical humidifier of claim 82, however is silent wherein the electrical connector comprises a Zener diode connected between the data line and the second power line for overvoltage protection.
However, Panarello teaches a power system for a respiratory therapy device (Abstract and Figure 1) comprising a Zener diode connected between the various circuitry lines for overvoltage protection (lock out circuit 702 may include a Zener Diode to prevent over voltage, Paragraph 0082 and Figure 7).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Liu’s device by including a Zener diode within the electrical circuitry, as taught by Panarello, as providing such a diode offers various benefits such as providing a stable, output voltage across a load, overvoltage protection, and a simple and compact design.
Claims 94-95 and 101 are rejected under 35 U.S.C. 103 as being unpatentable over Liu (WO 2017/043981 A1) in view of Buechi (US 2014/0299126 A1).
Regarding claim 94, Liu teaches the respiratory or surgical humidifier of claim 82, however is silent wherein the electrical connector further comprises a variable visual indicator for indicating status information to a user, wherein the variable visual indicator comprises a light-emitting diode (LED), wherein an output of the variable visual indicator is controlled based on an operating, configurational or environmental condition of the humidifier, and wherein controlling the output of the variable visual indicator comprises controlling an output color or temporal illumination pattern of the LED, wherein the electrical connector further comprises an LED line, wherein the LED is connected between the LED line and the ground line.
However, Buechi teaches a respiratory humidifier apparatus (Abstract, humidifier 1, Figure 1) comprising a variable visual indicator for indicating status information to a user, wherein the variable visual indicator comprises a light-emitting diode (light producing means 20 may comprise one or more LEDs such as a multi-color LED array, therefore offering the possibility of creating an alarm code, according to which different functional alarms are identified by separate colors, Paragraph 0016 and Figure 3), wherein an output of the variable visual indicator is controlled based on an operating, configurational or environmental condition of the humidifier, and wherein controlling the output of the variable visual indicator comprises controlling an output color or temporal illumination pattern of the LED (a control unit controls the function of the respiratory humidifier and if necessary, emits an optical signal when a functional state meriting an alarm is present, signal is generated by small LEDs forming the display elements, Paragraph 0005) wherein the electrical connector further comprises an LED line, wherein the LED is connected between the LED line and the ground line (as Buechi’s device comprises an LED electrically controlled via a control unit, it would therefore follow the system comprises an LED connected between an LED line and a ground line).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Liu’s device by including a variable visual indicator on the electrical connector to therefore display status information to the user, as taught by Beuchi, as providing a visual indication of the functionality of the humidifier provides the user and/or provider with a quick and effective means of system functionality.
Regarding claim 95, Beuchi further teaches wherein the output of the variable visual indicator is controlled based on a fault condition of the humidifier, and wherein the variable visual indicator is configured to produce a plurality different outputs corresponding to a plurality of respective fault conditions (light producing means 20 may comprise one or more LEDs such as a multi-color LED array, therefore offering the possibility of creating an alarm code, according to which different functional alarms are identified by separate colors, Paragraph 0016 and Figure 3).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Liu’s device by including a variable visual indicator on the electrical connector to therefore display status information to the user, such that the visual indicator is configured to produce a plurality of different outputs corresponding to a plurality of respective fault conditions, as taught by Beuchi, as providing a plurality of optical outputs provides the user and/or provider with a large range of alarm codes and/or indicators that the system may be experiencing a fault condition.
Regarding claim 101, Liu teaches the electrical connector of claim 100, however is silent wherein the electrical connector further comprises a variable visual indicator for indicating status information to a user, wherein the variable visual indicator comprises a light-emitting diode (LED), wherein an output of the variable visual indicator is controlled based on an operating, configurational or environmental condition of the respiratory or surgical humidifier, and wherein controlling the output of variable visual indicator comprises controlling an output color or temporal illumination pattern of the LED.
However, Buechi teaches a respiratory humidifier apparatus (Abstract, humidifier 1, Figure 1) comprising a variable visual indicator for indicating status information to a user, wherein the variable visual indicator comprises a light-emitting diode (light producing means 20 may comprise one or more LEDs such as a multi-color LED array, therefore offering the possibility of creating an alarm code, according to which different functional alarms are identified by separate colors, Paragraph 0016 and Figure 3), wherein an output of the variable visual indicator is controlled based on an operating, configurational or environmental condition of the humidifier, and wherein controlling the output of the variable visual indicator comprises controlling an output color or temporal illumination pattern of the LED (a control unit controls the function of the respiratory humidifier and if necessary, emits an optical signal when a functional state meriting an alarm is present, signal is generated by small LEDs forming the display elements, Paragraph 0005).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Liu’s device by including a variable visual indicator on the electrical connector to therefore display status information to the user, as taught by Beuchi, as providing a visual indication of the functionality of the humidifier provides the user and/or provider with a quick and effective means of system functionality.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached on (571)-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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