DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/24/2025.
Claim Objections
Claims 6 & 12 are objected to because of the following informalities:
Claim 6, line 15: “the humidity of a second fluid” should read “a humidity of a second fluid” to establish antecedent basis and for clarity.
Claim 12, line 3: “in the absence of the second fluid being supplied” should read “in an absence of the second fluid being supplied” to establish antecedent basis for the limitation.
Appropriate correction is required.
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 10 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 10 recites the limitation “a humidification setting of a humidifier” in lines 4-5. It is unclear if Applicant is attempting to recite the disclosure of the humidification setting of the humidifier in claim 6, or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the above limitation will be interpreted as – the humidification setting of the humidifier – as a recitation of the humidification setting of the humidifier in claim 6.
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.
Claims 6, 8, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hijnen & Bezemer (US 20170319104 A1), hereinafter Hijnen, in view of Arcilla et al. (US 20130263851 A1), hereinafter Arcilla.
Regarding claim 6, Hijnen discloses a computer-implemented method ([0019]) comprising:
receiving flow rate data, measured using a flow sensor (air flow sensor 10 measures flow rate; [0046]), the flow rate data indicative of a flow rate of a first fluid moving through a tube (air flow sensor 10 is part of breathing tube 6; Fig. 7; [0091]) for directing the first fluid from a nasal cavity of a subject to a location outside of the subject (breathing tube 6 can be placed in or at a nostril of a subject, hence exhaled air passing through breathing tube 6 is directed from a nasal cavity of the subject to a location outside of the subject; Fig. 1; [0045]);
receiving humidity data indicative of a humidity of the first fluid moving through the tube (humidity of air being exhaled by the subject as the air passes through breathing tube 6 is measured by a humidity sensor 8; [0046]);
determining, based on the flow rate data and/or the humidity data, a first time point at which the subject begins an exhalation (measurements from the air flow sensor 10 can be used to identify when the subject is inhaling and exhaling, hence the flow rate data is able to identify when a subject begins exhaling, where the point in time the patient begins exhaling is interpreted as a first time point; [0055]);
determining, based on the humidity data, a second time point during the exhalation at which the humidity of the first fluid reaches a defined humidity level (a time at which the humidity level of exhaled air is at a predetermined level is based on measurements of absolute humidity, where the humidity measured by the humidity sensor 8 is the absolute humidity, where the point in time the exhaled absolute humidity level reaches the predetermined level is interpreted as a second time point; [0082]);
determining, based on the flow rate data, a volume of the first fluid passing the flow sensor from the first time point to the second time point (volume of exhaled air is based on exhalation flow rates from the beginning of exhalation to the second time point; 0082], where TISB is the time when the humidity level reaches a predetermined level based on measurements of absolute humidity, see [0062]); and
comparing the volume of the first fluid to a reference volume (after measurements of absolute humidity and volume of exhaled air are obtained, said measurements are analyzed to determine a characteristic of the air that was above the ISB of the user, hence the volume of exhaled air is compared to a reference volume, where the reference volume is indicative of the user’s natural ISB; [0059]).
Hijnen further discloses the device (2) can be used to control ambient air conditions, such as temperature and humidity, for inhalation, and that device (2) can be implemented into a mechanical ventilator system to provide adjust the humidity of ventilator air according to the airway conditions of the subject as measured by the device (2; see [0080], [0092], and [0095]). Hijnen fails to explicitly disclose generating, based on the comparison, a signal to control a humidification setting of a humidifier such that the humidity of a second fluid to be supplied to the subject is updated.
However, Arcilla teaches a ventilation system (501) with a humidifier system (500), and controller (519), where the controller (519) includes a computer-implemented device and is connected with various valves and sensors that for part of the humidifier system ([0053] and [0057]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the computer-implemented method taught by Hijnen with the ventilator system and humidifier system as taught by Arcilla, such that computer-implemented method taught by Hijnen is implemented into a ventilator system (Arcilla: 501). Hence, Hijnen as modified by Arcilla teaches the controller taught by Arcilla includes the computer-implemented control method taught by Hijnen, so a signal to control a humidification setting of a humidifier, such that the humidity of a second fluid to be supplied to the subject is updated, is based on the comparison (device 2 of Hijnen, based off of comparison above, communicates data to the controller 519 as taught by Arcilla, such that the controller 519 taught by Arcilla generates a signal to adjust the humidity settings of humidifier system 500 as taught by Arcilla; see Hijnen [0080], [0092], and [0095], and Arcilla [0053] and [0057]) to provide accurate and controllable monitoring and manipulation of the humidity level of a gas delivered to a user for inhalation (Arcilla: [0053]).
Regarding claim 8, Hijnen, as modified, teaches the invention as set forth in claim 6, further comprising:
determining, at a third time point (a time point between the start of inhalation and the start of exhalation; [0081]), a reference humidity of the second fluid (relative humidity of inhaled gas; [0081]); and
applying, based on the reference humidity, a correction to the humidity data to account for the humidity of the second fluid to be supplied to the subject (based on the relative humidity of inhaled gas, the volume of exhaled gas is corrected for the ambient conditions around the device 2, where the humidity of inhaled gas is an ambient condition, hence the humidity data is corrected to account for the humidity of the inhaled gas to be supplied to the subject; [0015], [0053], and [0086]).
Regarding claim 15, Hijnen discloses a computer program product (control unit 12) comprising a non-transitory computer readable medium (memory module 14; [0047]), the computer readable medium having computer readable code embodied therein (memory module 14 stores computer readable program code; [0047]), but Hijnen fails to disclose the computer readable code being configured such that, on execution by a suitable computer or processor, the computer or processor is caused to perform the method of claim 6 as the control unit (12) does not generate, based on the comparison, a signal to control a humidification setting of a humidifier such that the humidity of a second fluid to be supplied to the subject is updated.
However, Arcilla teaches a controller (519), where the controller (519) includes a computer-implemented device, an associated memory, and other computer components for issuance of instructions ([0057]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the control unit taught by Hijnen with the controller taught by Arcilla, such that the controller taught by Hijnen, as modified by Arcilla, generates, based on the comparison (see claim 6 above), a signal to control a humidification setting of a humidifier, such that the humidity of a second fluid to be supplied to the subject is updated, is based on the comparison (device 2 of Hijnen, based off of comparison above, communicates data to the controller 519 as taught by Arcilla, such that the controller 519 taught by Arcilla generates a signal to adjust the humidity settings of humidifier system 500 as taught by Arcilla; see Hijnen [0080], [0092], and [0095], and Arcilla [0053] and [0057]) to provide accurate and controllable monitoring and manipulation of the humidity level of a gas delivered to a user for inhalation (Arcilla: [0053]).
Claims 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hijnen in view of Arcilla, as applied to claim 6 above, and further in view of Payton et al. (US 20190150831 A1), hereinafter Payton.
Regarding claim 7, Hijnen, as modified, teaches the invention as set forth in claim 6. Hijnen as modified is silent to determining, at a third time point (a time point between the start of inhalation and the start of exhalation; [0081]), a reference flow rate of the second fluid; and
applying, based on the reference flow rate, a correction to the flow rate data to account for the flow rate of the second fluid.
However, Payton teaches a controller to process gas sensor measurements or outputs and apply a correction factor to account for a flow rate of gas being delivered to the patient ([0106]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the controller of Hijnen, as modified in claim 6, with the function to apply a correction factor to account for a flow rate of gas being delivered to a patient, as taught by Payton (see Payton [0106], [0140], and [0382]; see Payton Figs. 5A-5B) to minimize the effect of interference and noise on the flow rate data (see Payton [0140]).
Regarding claim 14, Hijnen, as modified, teaches the invention as set forth in claim 6, but does not explicitly teach wherein the defined humidity level is in the range 30 to 44 mg/l H20 at 37 0C.
However, Payton teaches a defined humidity level about 44 mg/l of H2O at 37 0C ([0370]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the defined humidity level of the first fluid as taught by Hijnen, as modified in claim 6, with the defined humidity level of about 44 mg/l of H2O at 37 0C as taught by Payton (see Payton [0370]) to reach an ideal gas condition of the gas being provided to the user (Payton [0370]), preventing the user’s airway from drying out and improving patient comfort (Payton [0007]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hijnen in view of Arcilla, as applied to claim 6 above, and further in view of Burgess (US 20220016370 A1).
Regarding claim 9, Hijnen, as modified, teaches the invention as set forth in claim 6, further comprising:
determining, based on the flow rate data and/or the humidity data, a fourth time point at which the subject begins to inhale (measurements from air flow sensor 10 used to identify when the subject is inhaling, where the point in time when it is determined the subject has begun to inhale is interpreted as a fourth time point; [0055]). Hijnen as modified does not explicitly teach generating a signal to control a flow rate of the second fluid, such that the second fluid to be supplied to the subject between the first time point and the fourth time point is reduced.
However, Burgess teaches a controller (13) that adjusts the flow rate of gases being delivered to a user, such that the flow of gases delivered during expiration is lower than the flow of gases delivered during inspiration ([0003], [0005], and [0185]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the controller as taught by Hijnen, as modified in claim 6, with the control program taught by Burgess, such that the control taught by Hijnen, as modified, generating a signal to control a flow rate of the second fluid (controller 519 taught by Arcilla generates output signal to control flow of air to be inhaled as taught by the control method of Burgess; Burgess [0003], [0005], and [0010]), such that the second fluid to be supplied to the subject between the first time point and the fourth time point is reduced (control method of Burgess to adjust the flow rate such that the flow of gases delivered during expiration is lower than the flow of gases delivered during inspiration; Burgess [0003], [0005], and [0010]) to improve patient comfort (Burgess [0003]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hijnen in view of Arcilla, as applied to claim 6 above, and further in view of Novkov (US-20190344038 A1).
Regarding claim 10, Hijnen, as modified, teaches the invention as set forth in claim 6. Hijnen, as modified, further teaches the device (2) includes a user interface to allow the subject or a clinician to adjust controls of the device ([0049]). Hijnen, as modified, does not explicitly teach receiving a user preference to reduce or increase a level of humidity in the second fluid to be supplied to the subject; and
updating, based on the user preference, the generated signal to control a humidification setting of a humidifier.
However, Novkov teaches a ventilation humidification system with a controller (310) and a humidifier (300), where the controller (310) receives a user-selected humidity level for the gas to be supplied to the user, and an inspiratory flow command from the ventilator (100), such that the controller updates the humidity level of inspiratory flow to be delivered to the user with the user-selected humidity level (see [0049]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the controller taught by Hijnen, as modified in claim 6, with the control function taught by Novkov, such that the controller (Arcilla 519) further includes the function of receiving a user preference to reduce or increase a level of humidity in the second fluid to be supplied to the subject (user interface taught by Hijnen, see [0049]; Novkov [0049]); and updating, based on the user preference, the generated signal to control a humidification setting of a humidifier (Novkov [0049]) to provide a sufficient humidity level to the user (Novkov [0049]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hijnen in view of Arcilla, as applied to claim 6 above, and further in view of Seekup et al. (WO 2021229307 A1), hereinafter Seekup.
Regarding claim 11, Hijnen, as modified, teaches the invention as set forth in claim 6. Hijnen as modified does not teach generating an alert signal in response to determining that oscillations in the flow rate data exceed a defined frequency and/or in response to determining that the humidity of the first fluid falls below a threshold level.
However, Seekup teaches a controller to output an alarm if a humidity level of a gas falls below a first threshold value ([0009]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the controller as taught by Hijnen, as modified in claim 6, such that the controller of Hijnen as further modified by Seekup generates an alert signal in response to determining that the humidity of the first fluid falls below a threshold level (controller 519 as taught by Arcilla generates an alarm if the humidity of the exhaled gas falls below a threshold level, see Seekup [0009]) to notify the user of unsafe, or unsuccessful, therapy conditions.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hijnen in view of Arcilla, as applied to claim 6 above, and further in view of Liu et al. (WO 2017043981 A1), hereinafter Liu.
Regarding claim 12, Hijnen, as modified, teaches the invention as set forth in claim 6, wherein the reference volume (reference volume indicative of the user’s natural ISB, see claim 6 above) is determined based on data obtained in the absence of the second fluid being supplied to the subject (where the user’s natural ISB is determined based on data obtained without the influence of a fluid to be deliver to the user for inhalation, see the calculation of a volume characteristic the ISB of the user, where the volume characteristic of the ISB of the user is calculated from the first time point to the second time point, and is corrected for any ambient conditions around the device 2 and properties of the inhaled air; see [0085] – [0086]). Hijnen, as modified, fails to explicitly teach wherein the subject is to receive a supply of the second fluid via a second tube, and wherein the subject is to receive a supply of the second fluid via a second tube.
However, Liu teaches a respiratory device with a humidifier (Fig. 1), where the respiratory device has an inspiratory limb and an expiratory limb (Fig. 1; [0009]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device taught by Hijnen, as modified in claim 6, to include an inspiratory limb and an expiratory limb as taught by Liu, such that wherein the subject is to receive a supply of the second fluid via a second tube (user receives gas supplied to user for inhalation via inspiratory limb 202 taught by Liu; see Liu Fig. 1; see Liu [0009]), and wherein the reference volume is determined based on data obtained in the absence of the second fluid being supplied to the subject via the second tube (where the user’s natural ISB is determined based on data obtained without the influence of a fluid to be deliver to the user for inhalation, see the calculation of a volume characteristic the ISB of the user, where the volume characteristic of the ISB of the user is calculated from the first time point to the second time point, and is corrected for any ambient conditions around the device 2 and properties of the inhaled air, hence data used to determine the reference volume is obtained in the absence of gas being supplied to the user for inhalation via Liu’s inspiratory limb 202; see [0085] – [0086]) to improve patient comfort and control of humidity levels of a gas being supplied to a user (Liu [0006]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hijnen, in view of Arcilla, in view of Liu, as applied to claim 12 above, and further in view of Truschel & Hete (CN 111556770 A), hereinafter Truschel.
Regarding claim 13, Hijnen, as modified, teaches the invention as set forth in claim 12. Hijnen, as modified, is silent to generating an alert signal in response to determining that the volume of the first fluid deviates from the reference volume by a defined amount.
However, Truschel teaches a controller (160) with a monitor (1004) to determine when one or more respiratory parameters, including tidal volume, is not within a specified range of the patient, where the input threshold for the one or more respiratory parameters is a reference value ([0110], see provided translation). Truschel further teaches generating an alarm to when the one or more respiratory parameters are not within the input threshold ([0110], see provided translation).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the controller taught by Hijnen, as modified in claim 6, with the function of the controller taught by Truschel above, such that the controller (Arcilla 519) taught by Hijnen, as modified, can perform the function of generating an alert signal in response to determining that the volume of the first fluid deviates from the reference volume by a defined amount (when the volume of air exhaled deviates from the reference volume indicative of the user’s natural ISB, the controller, Arcilla 519, generates an alert signal using the control function taught by Truschel; Truschel [0110], see provided translation) to indicate an abnormal event has occurred (Truschel [0110], see provided translation) and the patient is not receiving sufficient therapy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Helleis (DE 102020119085 A1): Regarding a controller to initiate an alarm when a measured volume is within a desired threshold.
Novkov (US 20220072263 A1): Regarding control methods for a humidity alarm within a humidification and ventilatory support device.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785