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 .
Information Disclosure Statement
The information disclosure statements filed on 02/22/2024, 04/16/2024, 09/20/2024, 03/25/2025, 05/12/2025, 03/20/2026, and 07/28/2026 have been received and fully considered.
Claim Objections
Claims 32, 33, 37, and 57 are objected to because of the following informalities:
Claim 32 line 12 “an” should be corrected to “[[an]]” to avoid a redundant “an”.
Claim 33 line 1 “The method according to claim 1” should be corrected to “The method according to claim [[1]]32” for the sake of proper dependency.
Claim 37 line 2 “claim 23” should be corrected to “claim [[23]]32” for the sake of proper dependency.
Claim 57 line 2 “90L/min..” should be corrected to “90L/min.[[.]]” for the sake of proper punctuation.
Appropriate correction is required.
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.
Claims 32, 33, 37, 39, 42, and 54-57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US20170281051A1 to Evans et al. (hereinafter “Evans”).
Regarding claim 32, Evans discloses a method of determining a respiratory parameter of a patient during expiration when receiving respiratory support comprising (Fig. 4 generally discloses the method; Paragraph 0098 discloses measuring the concentration of a respiratory gas of interest of a total expiratory flow):
providing, to a patient, an apparatus gas flow with a flow rate and a gas proportion (Paragraph 0069 discloses providing gases to the patient at flow rates of 5-100L/min or more),
measuring a parameter of a gas present in a composite gas outflow from the patient (Paragraph 0099 discloses a sensor measuring a concentration of a gas of interest in a total expiratory flow),
determining a proportion of apparatus gas flow through the mouth and/or nose of the patient (Paragraph 0098 discloses determining delivered flow rate entering a patient’s nasal cavity from the apparatus (i.e. gas supply 130)),
determining an exhaled gas flow rate using one or more of: the gas proportion of the apparatus gas flow, the flow rate of the apparatus gas flow, the parameter of the gas present in the composite gas outflow, the proportion of the apparatus gas flow through the mouth and/or nose of the patient, an exhaled gas flow parameter, wherein the exhaled gas flow parameter is determined using the measured parameter of the gas present in the composite gas outflow and a time-varying flow rate or the gas proportion of the apparatus gas flow, and from the exhaled gas flow rate, determining one or more respiratory parameters (Fig. 4 steps 402, 404, 406, 408, 410, 412, 414 disclose the method of determining the patient’s exhaled flow rate; Paragraph 0099 discloses a second sensor may be any type of flow rate sensor capable of measuring the flow rate from the patient’s lungs, and may be located at or within the patient interface; Paragraph 0099 further discloses processor may remove the influence of the cannula flow from the total expiratory flow to determine the portion of the total expiratory flow that is attributed only to the patient exhaling. The result may be combined with the first sensor measurements to remove the portion of the measured concentration of the gas of interest in the total flow that is attributable to cannula flow leaving behind only the concentration of the gas of interest expired by the patient; Paragraphs 0104-112 disclose the process further).
Regarding claim 33, Evans discloses the method according to claim 32, and Evans further discloses wherein the one or more respiratory parameters comprise one or more of: a tidal volume (Paragraph 0097 discloses the presented methods can estimate end tidal gases during the breath cycle or over multiple breaths), a minute ventilation, a respiratory rate, apneic state, an airway patency, or a peak flow rate (Paragraph 0127 discloses a maximum flow rate may be determined over a period of time).
Regarding claim 37, Evans discloses the method according to claim 32, and Evans further discloses wherein the gas is one or more of 02, CO2 (Paragraph 0078 discloses the method may be used to measure end tidal CO2 of the patient’s expiration; Paragraph 0098 discloses the respiratory gas of interest may be CO2, oxygen, or nitrous oxide), N2, or a tracer gas.
Regarding claim 39, Evans discloses the method of claim 32, and Evans further discloses wherein one of the flow rate and gas proportion are time-varying of the apparatus gas flow (Paragraph 0069 discloses the flow rate delivered from the apparatus may vary per unit of time).
Regarding claim 42, Evans discloses the method of claim 32, and Evans further discloses wherein the exhaled gas flow parameter is an exhaled gas flow gas proportion (Paragraphs 0098 & 0099 discloses a sensor measuring a concentration of a gas of interest in a total expiratory flow and flow rate of the total expiratory flow).
Regarding claim 54, Evans discloses the method according to claim 32, and Evans further discloses further comprising a humidifying the apparatus gas flow (Figs. 1 & 2 humidification chamber 104).
Regarding claim 55, Evans discloses the method according to claim 32, and Evans further discloses wherein the apparatus gas flow is provided to the patient through a non-sealing interface (Paragraph 0086 discloses the interface 126 may be an unsealed nasal cannula, unsealed masks, controlled leak masks).
Regarding claim 56, Evans discloses the method according to claim 32, and Evans further discloses wherein the apparatus gas flow is provided at a flow rate of at least 15 L/min (Paragraph 0069 discloses providing gases to the patient at flow rates of 5-100L/min or more).
Regarding claim 57, Evans discloses the method according to claim 32, and Evans further discloses wherein the apparatus gas flow is provided at a flow rate from 20 L/min to 90 L/min (Paragraph 0069 discloses providing gases to the patient at flow rates of 5-100L/min or more).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 36, 38, 43, and 45-48 are rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of US20220265164A1 to Aylsworth (hereinafter “Aylsworth”).
Regarding claim 36, Evans discloses the method of claim 32, and Evans further discloses wherein the parameter of the gas present in the composite gas outflow is a gas proportion measured with a sensor (Paragraph 0098 discloses determining delivered flow rate entering a patient’s nasal cavity and Paragraph 0099 discloses determining gas concentration in an exhalation of a patient at the patient’s nose; See Fig. 1 conduit 120). Evans does not disclose measuring a parameter of gas with a sensor at the mouth. However, Aylsworth teaches a method and system of capnography which measures expiratory outflow with a sensor at the user’s mouth (Fig. 4 cannula 416, oral hose connection 414; Paragraph 0055 discloses the CO2 concentration of exhaled gas from the user’s mouth is measured via device 404).
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 Evans to further include a sensor for measuring a concentration in a patient’s exhaled gas at the mouth, as taught by Aylsworth, in order to provide measurements of CO2 coming from the user’s mouth during exhalation (Paragraph 0055).
Regarding claim 38, Evans in view of Aylsworth discloses the method of claim 36, and Evans further discloses further comprising determining a flow rate of the exhaled gas flow using all of: the gas proportion of the apparatus gas flow, the flow rate of the apparatus gas flow, the gas proportion of the composite gas, and the exhaled gas flow parameter (Fig. 4 steps 402, 404, 406, 408, 410, 412, 414 disclose the method of determining the patient’s exhaled flow rate; Paragraph 0099 discloses a second sensor may be any type of flow rate sensor capable of measuring the flow rate from the patient’s lungs, and may be located at or within the patient interface; Paragraph 0099 further discloses processor may remove the influence of the cannula flow from the total expiratory flow to determine the portion of the total expiratory flow that is attributed only to the patient exhaling. The result may be combined with the first sensor measurements to remove the portion of the measured concentration of the gas of interest in the total flow that is attributable to cannula flow leaving behind only the concentration of the gas of interest expired by the patient).
Regarding claim 43, Evans discloses the method according to claim 32, but Evans does not disclose wherein determining a proportion of apparatus gas flow through the mouth and/or nose comprises determining a proportion of apparatus gas flow through the mouth. However, Aylsworth teaches a method and system of capnography which measures expiratory outflow with a sensor at the user’s mouth (Fig. 4 cannula 416, oral hose connection 414; Paragraph 0055 discloses the CO2 concentration of exhaled gas from the user’s mouth is measured via device 404).
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 Evans to further include a sensor for measuring a concentration in a patient’s exhaled gas from the mouth, as taught by Aylsworth, in order to provide measurements of CO2 coming from the user’s mouth during exhalation (Paragraph 0055).
Regarding claim 45, Evans discloses the method of claim 42, and Evans further discloses wherein the exhaled gas flow: QE is the exhaled gas flow rate (Paragraph 0108 discloses total expiratory flow rate (QE)),
QO is the flow rate of the apparatus gas flow (Paragraph 0116 cannula flow rate QC),
Fo is the gas proportion of the apparatus gas flow (Paragraph 0120 discloses concentration of CO2 in the cannula flow the cannula CC),
Fm is the parameter of the gas present in the composite gas outflow from the patient (Paragraph 0121 discloses flow rate of CO2 from the cannula QC,CO2), and
FE is the exhaled patient gas flow parameter (Paragraph 0114 discloses patient only contribution to expiratory CO2 flow rate QP,CO2). Evans does not disclose k is the proportion of the apparatus gas flow that exiting through the mouth, wherein k = 0 represents the patient's mouth being closed. However, Aylsworth teaches a method and system of capnography which measures expiratory outflow with a sensor at the user’s mouth and accounts for when the user’s mouth is closed (Fig. 4 cannula 416, oral hose connection 414; Paragraph 0055 discloses the CO2 concentration of exhaled gas from the user’s mouth is measured via device 404 (i.e. proportion which is exiting the mouth); Paragraph 0053 discloses a scenario where the nares are open and the mouth is closed as part of the CO2 exhalation calculation (i.e. K=0)).
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 Evans to further include a sensor for measuring a concentration in a patient’s exhaled gas at the mouth, as taught by Aylsworth, in order to provide measurements of CO2 coming from the user’s mouth during exhalation (Paragraph 0055). Modified Evans does not explicitly disclose determining exhaled flow rate based on:
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However, Evans teaches a function to determine an exhaled flow rate of a patient using the determined concentration of the gas of interest present in the total expiratory gas outflow and cannula flow rate where the gas of interest is CO2 (Paragraphs 0114-0123).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to discover the optimal workable ranges since the general conditions of the claimed methods are disclosed in the prior art and there are a finite number of identified predictable solutions to calculate an exhaled flow rate from a patient’s lungs when provided the flow rate of the apparatus gas flow, the gas proportion of the apparatus gas flow, the parameter of the gas present in the composite gas outflow from the patient, the exhaled patient gas flow parameter, and k is the proportion of the apparatus gas flow that exiting through the mouth, wherein k = 0 represents the patient's mouth being closed. See MPEP 2144.05(II)(A).
Regarding claim 46, Evans in view of Aylsworth discloses the method of claim 45, and Evans as modified by Aylsworth further discloses wherein the exhaled gas flow parameter is determined using a time-varying flow rate of the apparatus gas flow (Paragraphs 0069, 0098, and 0114-0123 disclose cannula flow being varied per unit of time), and the composite gas outflow gas parameter (FM) is a volume fraction of 02 (Paragraph 0078 discloses the method may be used to measure end tidal CO2 of the patient’s expiration; Paragraph 0098 discloses the respiratory gas of interest may be CO2, oxygen, or nitrous oxide). Modified Evans does not explicitly disclose wherein the exhaled gas flow parameter (FE) is determined based on:
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However, Evans teaches finding an exhaled flow gas of interest wherein the exhaled gas flow parameter is determined using a time-varying flow rate of the apparatus gas flow and the composite gas outflow gas parameter (FM) is a volume fraction of 02 (Paragraphs 0069, 0078, 0098, and 0114-0123). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to discover the optimal workable ranges since the general conditions of the claimed methods are disclosed in the prior art and there are a finite number of identified predictable solutions to calculate an exhaled gas flow parameter based on the exhaled gas flow parameter is determined using a time-varying flow rate of the apparatus gas flow and the composite gas outflow gas parameter (FM) is a volume fraction of 02. See MPEP 2144.05(II)(A).
Regarding claim 47, Evans in view of Aylsworth discloses wherein the exhaled gas flow parameter is determined using a time-varying flow rate of the apparatus gas flow (Paragraphs 0069, 0098, and 0114-0123 disclose cannula flow being varied per unit of time), and the composite gas outflow parameter (FM) is a volume fraction of CO2 (Paragraph 0078 discloses the method may be used to measure end tidal CO2 of the patient’s expiration; Paragraph 0098 discloses the respiratory gas of interest may be CO2, oxygen, or nitrous oxide). Modified Evans does not explicitly disclose wherein the exhaled gas flow parameter (FE) is determined based on:
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However, Evans teaches finding an exhaled flow gas of interest wherein the exhaled gas flow parameter is determined using a time-varying flow rate of the apparatus gas flow and the composite gas outflow gas parameter (FM) is a volume fraction of C02 (Paragraphs 0069, 0078, 0098, and 0114-0123). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to discover the optimal workable ranges since the general conditions of the claimed methods are disclosed in the prior art and there are a finite number of identified predictable solutions to calculate an exhaled gas flow parameter based on the exhaled gas flow parameter is determined using a time-varying flow rate of the apparatus gas flow and the composite gas outflow gas parameter (FM) is a volume fraction of C02. See MPEP 2144.05(II)(A).
Regarding claim 48, Evans in view of Aylsworth discloses the method according to claim 45, and Evans as modified by Aylsworth further discloses wherein the exhaled gas flow parameter is determined using a time-varying oxygen fraction of the apparatus gas flow (Paragraphs 0069, 0098, and 0114-0123 disclose cannula flow being varied per unit of time), and the composite gas outflow parameter (FM) is a volume fraction of 02 (Paragraph 0078 discloses the method may be used to measure end tidal CO2 of the patient’s expiration; Paragraph 0098 discloses the respiratory gas of interest may be CO2, oxygen, or nitrous oxide). However, modified Evans does not explicitly disclose wherein the exhaled gas outflow parameter (FE) is determined based on:
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However, Evans teaches finding an exhaled flow gas of interest wherein the exhaled gas flow parameter is determined using a time-varying flow rate of the apparatus gas flow and the composite gas outflow gas parameter (FM) is a volume fraction of 02 (Paragraphs 0069, 0078, 0098, and 0114-0123). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to discover the optimal workable ranges since the general conditions of the claimed methods are disclosed in the prior art and there are a finite number of identified predictable solutions to calculate an exhaled gas flow parameter based on the exhaled gas flow parameter is determined using a time-varying flow rate of the apparatus gas flow and the composite gas outflow gas parameter (FM) is a volume fraction of 02. See MPEP 2144.05(II)(A).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Evans.
Regarding claim 40, Evans discloses the method according to claim 39, but does not explicitly disclose wherein the flow rate oscillates. However, Evans does teach the cannula flow rate could be altered during expiration to provide a lower flow rate (Paragraph 0234). Evans further discloses this idea can be extended to techniques that alter the cannula flow from a constant high flow to be an oscillatory flow (Paragraph 0234).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Evans such that the cannula flow rate oscillates in order to more easily detect the concentration of the gas of interest (Paragraph 0234).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over US20190150831A1 to Payton et al. (hereinafter “Payton”).
Regarding claim 41, Evans discloses the method according to claim 40, and Evans does not disclose wherein the flow rate oscillates at a frequency greater than a breathing frequency of the patient. However, Payton teaches a system for determining airway patency where the flow rate oscillates at a frequency greater than a breathing frequency of the patient (Figs. 13A & B the flow rate varies in a shorter time frame (frequency) than CO2 being expelled from the patient’s lungs (in Fig. 13B); Paragraph 0537 discloses the frequency difference is used to assist in oxygenation of the patient and helps in CO2 clearance due to flushing).
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 Evans to have a flow rate which oscillates at a frequency greater than a breathing frequency of the patient, as taught by Payton, in order to provide assistance with oxygenation of the patient and clearance of CO2 (Paragraph 0537).
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of Aylsworth as applied to claim 45 above, and further in view of US20190255272A1 to Rapoport et al. (hereinafter “Rapoport”).
Regarding claim 49, Evans in view of Aylsworth discloses the method according to claim 45, and Evans as modified by Aylsworth further discloses wherein the one or more respiratory parameters include tidal volume (VTidal) (Paragraph 0097 discloses the presented methods can estimate end tidal gases during the breath cycle or over multiple breaths). Evans does not explicitly disclose wherein tidal volume can be determined based on:
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However, Rapoport teaches a method of controlling a device for delivering respiratory therapy which integrates the exhalation phase of the patient over time to determine the tidal volume (Fig. 2B “E” expiration phase; Paragraph 0139 discloses a maximum tidal volume for both inspiration phase and an expiration phase using simple integration of flow rate; Examiner notes the x-axis is time (i.e. (t)dt); Paragraphs 0143 and 0145 disclose integrating the exhalation phase signal over a period of time).
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 Evans to find tidal volume by integrating the expiration phase over time, as taught by Rapoport, in order to determine a volume of air in the lungs at the end of the expiration phase (Paragraphs 0139, 0141, & 0145).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-20220040428-A1 to Fogarty; US-20210386959-A1 to Oddo; US-20210299388-A1 to Vankoevering; US-20210282736-A1 to Stamatpoulos; US-20210093819-A1 to Romano; US-20210059616-A1 to Abrol; US-20210052839-A1 to Li; US-20200001037-A1 to Liu; US-20180272094-A1 to Eves; US-20180235511-A1 to Kerster; US-20180207386-A1 to Kerster; US-20180185598-A1 to Olsen; US-20180120245-A1 to Dill; US-20180064898-A1 to Evans; US-20180043125-A1 to Bencke; US-20180043121-A1 to Goulitski; US-20170367619-A1 to Zhan; US-20170325716-A1 to Coleman; US-20170325695-A1 to Freeman; US-20170014587-A1 to Whiting; US-20160370213-A1 to Stromsten; US-20160193438-A1 to White; US-20120302910-A1 to Freeman; US-20120192867-A1 to Lewis; US-20120137250-A1 to Milne; US-20100078024-A1 to Andrieux; US-20090159079-A1 to Meier; US-20090056409-A1 to Howard; US-20080257349-A1 to Hedner; US-20140194703-A1 to Wondka; US-20140171817-A1 to Blanch; US-20130060157-A1 to Beard; US-20130060110-A1 to Lynn; US-20130032147-A1 to Robinson; and US-20130006134-A1 to Doyle.
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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