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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/24/2026 has been entered.
Response to Amendment
The amendment filed on 06/24/2026 has been entered. Claim 1 has been amended. No claims have been newly added nor cancelled. Claims 1, 41-48, and 52-54 remain pending in the instant application.
Response to Arguments
Applicant's arguments and Declaration under 37 C.F.R. 1.132 filed 06/24/2026 have been fully considered but they are not persuasive.
The Applicant's Declaration under 37 C.F.R. 1.132 is acknowledged. The content of the Declaration appears to be supportive of similar arguments presented on Pages 8-11 of the Remarks filed on 06/24/2026. Thus, Applicant's Declaration will be treated as opinion evidence per MPEP 716.01(c). The Applicant's Declaration will be treated and responded to simultaneously with the arguments referenced above.
Regarding claim 1, Applicant argues that Harrington is not analogous art and therefore is improperly combined with Zucchi to reject claim 1 (Remarks page 7, 2nd Paragraph). Specifically, Applicant argues that Harrington is not directed to the same field of endeavor as the invention (Remarks Page 8, 2nd Paragraph). It is examiner’s position that Harrington remains within the same field of endeavor as Applicant’s invention. The MPEP states that “When determining whether the "relevant field of endeavor" test is met, the examiner should consider "explanations of the invention’s subject matter in the patent application, including the embodiments, function, and structure of the claimed invention." See MPEP 2141.01(a)(I). The Harrington reference was used in the rejection of claim 1 for teaching the limitation of “wherein the temperature indicating element is impregnated into at least a portion of the material forming the heat and moisture exchanger” (Final Rejection mailed on 09/26/2025 at Section 7). The claimed invention also has the same structure as Harrington (Harrington Fig. 15 temperature sensors 5514_HE; Paragraph 0348; Examiner notes the sensor is embedded within the humidifier walls). Thus, in the present case, both the claimed invention and the prior art reference Harrington share the same structure and are considered to be within the same field of endeavor. Accordingly, Applicant’s argument is found to be unpersuasive.
Applicant then argues Harrington is not reasonably pertinent to the problem face by the inventor (Remarks page 9, Heading of Page). Examiner notes the analogous art test merely requires the prior art reference to be either (1) from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem face by the inventor (even if it is not in the same field of endeavor as the claimed invention). Point (1) has already been addressed and thus examiner will not address point (2). Accordingly, Applicant’s arguments regarding claim 1 are found to be unpersuasive.
Regarding claim 48, it is examiner’s position Harrington remains analogous art and therefore Applicant’s argument is found to be unpersuasive.
Claim Objections
Claim1 is objected to because of the following informalities:
Claim 1 line 20 “the at least a portion” should be corrected to “.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 41, 45, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over US20090078251A1 to Zucchi et al. (hereinafter “Zucchi”) in view of US2016/0051780A1 to Sherman et al. (hereinafter “Sherman”), US20180056024A1 to Harrington et al. (hereinafter “Harrington”) and US2016/0250438A1 to Harwood et al. (hereinafter “Harwood”).
Regarding claim 1, Zucchi discloses a system for detecting the use of a heated humidifier with a heat and moisture exchanger in a respiratory circuit, the system comprising (Fig. 1 system 100, heat and moisture exchanger 50):
a heat and moisture exchanger defining at least a portion of the respiratory circuit, and configured to exchange air between a patient and a ventilator (Fig. 1 heat and moisture exchanger 50); and
a temperature indicating element coupled to the heat and moisture exchanger configured to provide an indication that the heat and moisture exchanger is used in combination with a heated humidifier based on a temperature differential between the air exchanged with the patient and the air exchanged with the ventilator in the respiratory circuit (Fig. 1 temperature-regulated conduits 10, 20, 30, temperature sensors 80, 90; Fig. 1 shows temperature sensors 80, 90 are fluidically coupled to the heat and moisture exchanger 50; Paragraphs 0056-0057 discloses the temperature sensors are used to control the temperature regulated conduits; Specifically, Paragraph 0056 discloses both sensors 80, 90 detect the temperature of the gas supply in conduits 10, 20, and 30. A thermostat then controls the temperature via the readings of the temperature sensors. Paragraph 0057 discloses the conduits heat the gas by gathering more moisture from the water reservoir. Paragraph 0057 also discloses the HME works with the internal water reservoir RS to either have warmer moisturized gas or cooler dry gas for the patient once the air is in the inhaling path based on the sensor readings. Thus, the sensors are indicating the HME is properly working with the water reservoir (humidifier) to put moisture and heat into the air on the ventilator side when compared to the readings in the patient side of the respiratory circuit.); wherein the heat and moisture exchanger comprises a patient-end chamber coupled to a patient-side opening for exchanging air with the patient (Zucchi Fig. 1 bottom half of heat and moisture exchanger 50 is connected to ventilator 60 and patient side (PZ)), and a ventilator-end chamber coupled to at least one ventilator-side opening for exchanging air with the ventilator (Zucchi Fig. 1 top half of HME 50 is coupled to ventilator 60 via element 61; Examiner notes the arrows going to the ventilator 60 are indicative of air flow), and wherein the temperature indicating element is configured to provide an indication that the temperature in the ventilator-end chamber is at and/or above a selected threshold (Fig. 1 temperature sensor 90; Paragraphs 0047-0048 disclose the temperatures are controlled by a thermostat based on the temperature sensor readings; Examiner notes that the thermostat is controlling the temperatures based on certain temperature thresholds); and wherein the at least a portion of the material forming the heat and moisture exchanger comprises the ventilator end chamber (Examiner notes the top half of HME 50 (ventilator-end chamber) is comprised of the material forming the HME 50 (on the designated ventilator-end chamber’s bottom wall)).
Zucchi does not disclose a safety warning system. However, Sherman teaches a ventilator which uses a safety warning system (Fig. 1 CPU 200, alarm 220; Paragraph 0047 discloses the CPU includes an alarm module; Paragraph 0015 generally describes the alarm function).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Zucchi to further include a ventilator safety alarm, as taught by Sherman, in order to provide an alert if one or more parameters exceed or fail to exceed predetermined values of the system while operating (Paragraph 0015).
Zucchi does not disclose wherein the patient-end chamber and ventilator-end chamber are separated by a porous material. However, Harwood teaches an adjustable heat and moisture exchanger which uses a porous material (Figs. 12a & b HME 120, sponge 129; Paragraph 0201 discloses the HME may use a sponge or other porous material; Motivation in order to provide a means to retain water (Paragraph 0201)).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Zucchi to further include porous material in the HME, as taught by Harwood, in order to provide an additional means to retain water (Paragraph 0201).
Zucchi does not disclose wherein the temperature indicating element is impregnated into at least a portion of the material forming the heat and moisture exchanger. However, Harrington teaches a system and method of conditioning respiratory gases that has temperature sensors embedded in the humidifier portion (Harrington Fig. 15 temperature sensors 5514_HE; Paragraph 0348; Examiner notes the sensor is embedded within the humidifier 5000 walls).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Zucchi to have a temperature sensor embedded into a portion of the heat and moisture exchanger, as taught by Zucchi, in order to provide direct temperature measurement along the humidifier (Paragraphs 0345-0348).
Regarding claim 41, Zucchi in view of Sherman, Harrington, and Harwood discloses the safety warning system of claim 1, and Zucchi as modified by Harrington further discloses wherein the temperature indicating element is coupled to at least one of (i) the at least one ventilator-side opening and (ii) a tube coupled to the at least one ventilator-side opening (Zucchi Fig. 1 temperature sensor 90 is coupled to a ventilator side opening (See annotated Fig. 1); Examiner notes that openings along the exhale branch EB are considered ventilator-side openings; Examiner further notes impregnating the sensor into the side of the HME (via Harrington) still results in the sensor being coupled to the ventilator-side opening).
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Regarding claim 45, Zucchi in view of Sherman, Harrington, and Harwood discloses the safety warning system of claim 1, and Zucchi further discloses wherein the temperature indicating element comprises an electronic temperature sensor configured to send signals indicative of the temperature in at least a portion of the respiratory circuit (Zucchi Fig. 1 temperature sensors 80, 90; Paragraphs 0047-0048 disclose the sensors are electrically connected to the thermostat and the sensors measure the temperature regulated conduits 10, 20, 30). Zucchi does not disclose wherein the signals are sent to a remote device. However, Harrington teaches a ventilator which communicates data from the ventilator to a remote device (Fig. 4c data communication interface 4280; Paragraph 0240 discloses the interface may be located remotely from the ventilator; Paragraphs 0358 and 0378 disclose sending temperature information to the remote data communication interface).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Zucchi to further include information being relayed to a remote device, as taught by Harrington, to allow easy accessibility to an appropriately authorized person such as a clinician (Paragraph 0244).
Regarding claim 47, Zucchi in view of Sherman, Harrington, and Harwood discloses the safety warning system of claim 1, and Zucchi as modified by Harrington further discloses wherein the temperature indicating element is impregnated into at least a portion of (i) the material forming the heat and moisture exchanger (Harrington Fig. 15 temperature sensors 5514_HE; Paragraph 0348; Examiner notes the sensor is embedded within the humidifier 5000 walls), (ii) the at least one ventilator-side opening , (iii) the tube coupled to the at least one ventilator-side opening and (iv) the porous material that separates the patient-end chamber from the ventilator-end chamber.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Zucchi in view of Sherman, Harrington, and Harwood as applied to claim 1 above, and further in view of US20170035978A1 to Holley et al. (hereinafter “Holley”).
Regarding claim 42, Zucchi in view of Sherman, Harrington, and Harwood discloses the safety warning system of claim 1, but does not disclose wherein the temperature indicating element is sealed from the respiratory circuit. However, Holley teaches a ventilator which uses external sensors on a humidifier (Fig. 5a - Fig. 5c humidifier 5000, humidifier sensors 5210, temperature sensor 5216; Paragraphs 0309 and 0315 discloses the humidity sensor/temperature sensors may be external to the humidifier).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Zucchi to have temperature sensors sealed from the respiratory circuit, as taught by Holley, to provide measurement of the temperature of the ambient air (Paragraph 0315).
Claims 43 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Zucchi in view of Sherman, Harrington, and Harwood as applied to claim 1 above, and further in view of US2012/0125333A1 to Bedford et al. (hereinafter “Bedford”).
Regarding claim 43, Zucchi in view of Sherman, Harrington, and Harwood discloses the safety warning system of claim 1, but does not disclose wherein the temperature indicating element comprises a thermochromic pigment. However, Bedford teaches a ventilator which uses a thermochromic temperature sensor (Paragraph 0129 discloses using a thermochromic thermometer).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature sensor of Zucchi to be made with thermochromic pigment, as taught by Bedford, to allow patients and nurses to monitor the temperature and observe temperature change without the need for exact readings from displays (Paragraph 0120).
Regarding claim 44, Zucchi in view of Sherman, Harrington, and Harwood discloses the safety warning system of claim 1, but does not disclose wherein the temperature indicating element is configured to be opaque when the temperature is below a selected threshold, and to be clear to reveal a warning when the temperature is at or above a selected threshold. However, Bedford teaches a ventilator which uses a thermochromic temperature sensor (Paragraph 0129 discloses using a thermochromic thermometer; Paragraph 0120 discloses the thermochromic material may be used to visualize warning messages when the parts are heated to a certain level; Examiner notes the thermochromic material must go from being opaque to being clear relative to differentiating the warning message from the rest of system).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature sensor of Zucchi to be made with thermochromic pigment, as taught by Bedford, to allow patients and nurses to monitor the temperature and observe temperature change without the need for exact readings from displays (Paragraph 0120).
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Zucchi in view of Sherman, Harrington, and Harwood as applied to claim 39 above, and further in view of US2017/0239404A1 to Shavit (hereinafter “Shavit”).
Regarding claim 46, Zucchi in view of Sherman, Harrington, and Harwood discloses the safety warning system of claim 1, but do not disclose wherein the temperature indicating element is provided as a laminated tab or disc within the ventilator-end chamber of the heat and moisture exchanger. However, Shavit teaches a temperature sensor used in monitoring biological substances (Fig. 1 sensor 25; Paragraph 0123 discloses the sensor may be a temperature sensor; Paragraphs 0103-0106 disclose the temperature sensor may be in the shape of a disc).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Zucchi to have a disc temperature sensor, as taught by Shavit, to provide an alternative manner of temperature assessment as an obvious design choice. (Paragraph 0103).
Claims 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over Zucchi in view of US20090301478A1 to Ohmura (hereinafter “Ohmura”) and Harrington.
Regarding claim 48, Zucchi discloses a device for detecting temperature in a heat and moisture exchanger, the device having a temperature indicating element (Fig. 1 system 100, heat and moisture exchanger 50; Fig. 1 temperature-regulated conduits 10, 20, 30, temperature sensors 80, 90), the temperature indicating element device being disposed within a respiratory circuit (Fig. 1 sensor 90 is within the respiratory circuit).
Zucchi does not disclose a temperature indicating element disposed for providing an indication of an air temperature within the heat and moisture exchanger received from a tube that extends from a ventilator toward the patient. However, Ohmura teaches a heat and moisture exchanger which has a temperature sensor which is indicative of air temperature received from a ventilator toward the patient (Fig. 10 lung simulator 1 (the patient), ventilator 3, temperature & humidity sensor 7A; Examiner notes the temperature sensor 7A is positioned to give temperature readings from the ventilator before entering the HME. Thus the readings would be indicative of the temperature of the air flow that initially enters the HME.).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Zucchi to further include a temperature sensor providing readings indicative of air temperature received from a ventilator toward the patient, as taught by Ohmura, in order to provide an initial measurement of the temperature going into the heat and moisture exchanger. Examiner notes this modification would result in a more efficient system as the electronic control unit of Zucchi would know precisely how much the incoming airflow needs heated to achieve the proper therapeutic level.
Zucchi does not disclose wherein the temperature indicating element is disposed on an inner surface of the heat and moisture exchanger. However, Harrington teaches a system and method of conditioning respiratory gases that has temperature sensors embedded in the humidifier portion (Harrington Fig. 15 temperature sensors 5514_1-4; Paragraph 0345; Examiner notes the sensors are embedded into the humidifier 5000).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Zucchi to have a temperature sensor embedded into a portion of the heat and moisture exchanger, as taught by Zucchi, in order to provide direct temperature measurement along the humidifier (Paragraphs 0345-0346).
Claims 52-54 are rejected under 35 U.S.C. 103 as being unpatentable over Zucchi in view of Ohmura and Harrington as applied to claim 48 above, and further in view of Bedford.
Regarding claim 52, Zucchi in view of Ohmura and Harrington discloses the device of claim 48, but does not disclose wherein said temperature indicating element includes an element impregnated with at least one substance that changes colour or becomes transparent with variation in temperature. However, Bedford teaches a ventilator which uses a thermochromic temperature sensor (Paragraph 0129 discloses using a thermochromic thermometer; Paragraph 0120 discloses the thermochromic material may be used to visualize warning messages when the parts are heated to a certain level; Examiner notes the thermochromic material must go from being opaque to being clear relative to differentiating the warning message from the rest of system).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature sensor of Zucchi to be made with thermochromic pigment, as taught by Bedford, to allow patients and nurses to monitor the temperature and observe temperature change without the need for exact readings from displays (Paragraph 0120).
Regarding claim 53, Zucchi in view of Ohmura and Harrington discloses the device of claim 48, but does not disclose wherein the device uses at least one of (i) a thermochromic pigment and (ii) liquid crystal technology as an indicator. However, Bedford teaches a ventilator which uses a thermochromic temperature sensor (Paragraph 0129 discloses using a thermochromic thermometer; Paragraph 0120 discloses the thermochromic material may be used to visualize warning messages when the parts are heated to a certain level; Examiner notes the thermochromic material must go from being opaque to being clear relative to differentiating the warning message from the rest of system).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature sensor of Zucchi to be made with thermochromic pigment, as taught by Bedford, to allow patients and nurses to monitor the temperature and observe temperature change without the need for exact readings from displays (Paragraph 0120).
Regarding claim 54, Zucchi in view of Ohmura and Harrington discloses the device of claim 48, but does not disclose reveals symbols or words when a colour change occurs in a thermochromic element of the temperature indicating element. However, Bedford teaches a ventilator which uses a thermochromic temperature sensor (Paragraph 0129 discloses using a thermochromic thermometer; Paragraph 0120 discloses the thermochromic material may be used to visualize warning messages when the parts are heated to a certain level; Examiner notes the thermochromic material must go from being opaque to being clear relative to differentiating the warning message from the rest of system).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature sensor of Zucchi to be made with thermochromic pigment, as taught by Bedford, to allow patients and nurses to monitor the temperature and observe temperature change without the need for exact readings from displays (Paragraph 0120).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-20090301475-A1 to Korneff; EP-2113278-A1 to Zucchi; and EP-1042034-B1 to Martin.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TYLER RAUBENSTRAW whose telephone number is (571)272-0662. The examiner can normally be reached Monday-Friday 7:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BRANDY LEE can be reached at 571-270-3525. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TYLER A RAUBENSTRAW/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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