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
This Office Action is in response to the amendment filed on 02/23/2026. Claims 1-9 and 28-57 are canceled. Claims 10-11, 13-17, 19-22, and 27 are as amended. Claims 12, 18, and 23-26 are as previously presented. As such, claims 10-27 are pending in the instant application.
All claim objections and 35 U.S.C. 112(b) rejections presented in the Office Action mailed on 08/15/2025 have been withdrawn in light of the amendments.
Claim Objections
Claims 15, 17, 19-21, and 27 are objected to because of the following informalities:
Claims 15, line 4: “the exhaled as flow” should read “the exhaled gas flow” for consistency and clarity.
Claim 15, line 18: “at time t and t+∆t” should read “at time t” for consistency and clarity.
Claim 17, line 7: “FE(t) is a CO2 and/or O2 concentration” should read “FE(t) is a CO2 concentration and/or an O2 concentration” for clarity.
Claim 19, line 2: “and second flow rate” should read “and the second flow rate” for clarity.
Claim 20, line 2: “and second flow rate” should read “and the second flow rate” for clarity.
Claim 21, line 2: “and second flow rate” should read “and the second flow rate” for clarity.
Claim 27, lines 3-4: “and only a time-varying parameter of the time-varying parameter being a flow rate” should read “and only a time-varying parameter, wherein the time varying parameter is a flow rate” for clarity.
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.
Claims 15-17 and 22 are 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 15 recites the limitation "the time-varying flow rate component" in line 6. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the above limitation will be interpreted as – the time-varying flow rate.
Claim 16 recites the limitation "the time-varying flow rate component" in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the above limitation will be interpreted as – the time-varying flow rate.
Claim 17 recites the limitation "the time-varying flow rate component" in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the above limitation will be interpreted as – the time-varying flow rate.
Claim 22 recites the limitation "the time-varying flow rate component" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the above limitation will be interpreted as – the time-varying flow rate.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 10-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of claims 10-27 have been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of claims 10-27 recites at least one step or instruction for observation, judgement, and evaluation, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. The claims involve determining a parameter of a gas present in a composite gas outflow from a patient, determining the parameter of the gas present in an exhaled gas flow, and providing an output of an indication related to the parameter of the gas present in the exhaled gas flow. Accordingly, each of claims 10-27 recites an abstract idea.
Specifically, claim 10 recites,
an apparatus gas flow rate with a time-varying flow rate;
a composite gas outflow from a patient;
a leak gas flow;
an exhaled gas flow;
determining, at two time points, a parameter of a gas present in a composite gas outflow from the patient (observation, judgement or evaluation, which is grouped as a mental process under the 2019 PEG);
determining the parameter of the gas present in the exhaled gas flow based on the determined parameter of the gas present in the composite gas outflow at the two time points and the time-varying flow rate at the two time points (observation, judgement or evaluation, which is grouped as a mental process under the 2019 PEG);
providing an output comprising an indication related to the parameter of the gas present in the exhaled gas flow (observation, judgement or evaluation, which is grouped as a mental process under the 2019 PEG).
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent claims 11-27 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A, Prong 2
The above-identified abstract idea in independent claim 10 (and its respective dependent claims 11-27) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent claim 10), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of an apparatus gas flow rate with a time-varying flow rate, a composite gas outflow from a patient, a leak gas flow, and an exhaled gas flow as recited in independent claim 10 and its dependent claims do not serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. For at least these reasons, the abstract idea identified above in independent claim 10 (and its respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a generic flow apparatus (e.g., an apparatus gas flow rate with a time-varying flow rate as claimed). In other words, these claims are merely directed to an abstract idea with additional generic elements that are well-known within the respiratory technical field which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a generic flow apparatus. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claim 10 (and its respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent claim 10 (and its respective dependent claims) is directed to an abstract idea under 2019 PEG.
Step 2B
None of claims 10-27 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: an apparatus gas flow rate with a time-varying flow rate, a composite gas outflow from a patient, a leak gas flow, and an exhaled gas flow as recited in independent claim 10 and its dependent claims.
The above-identified additional elements are generically claimed components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. As such, the additional elements listed above amount to no more than an insignificant extra-solution activity or a generic component that is well-understood, routine, and conventional (Examiner’s Note: see Tatkov et al. (US 20150128942 A1), which discloses the supply of an apparatus gas flow with a time-varying flow rate; see Tatkov et al. [0068], lines 1-5, [0084], lines 9-12, and [0093], lines 14-18). See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, “a patient is provided a gas flow from a respiratory apparatus 10 for providing therapy (such as, a high gas flow for, but not limited to, high flow therapy). The apparatus 10 provides an apparatus gas flow 11. This apparatus gas flow 11 has a flow rate. The flow rate might be a constant flow rate (that is not varying over time), or it might be time-varying, depending on the requirements of therapy” (see US PGPub 20230116240 A1 [0223]), “ exhaled gas flow 13 will have constituent gas components, such as CO.sub.2, O.sub.2, Nitrogen, Helium and the like. The exhaled gas flow 13 may also comprise anaesthetic agents, such as sevoflurane” (see US PGPub 20230116240 A1 [0223]), ““Leak gas flow” 12 comprises the excess gas flow from the apparatus gas flow 11 that is not inhaled and/or has not entered the lower airways of the patient by the patient and escapes to ambient via the mouth and/or nose” (see US PGPub 20230116240 A1 [0225]), and ““Composite gas outflow” is the leak gas flow 12 combined with the exhaled gas flow 13” (see US PGPub 20230116240 A1 [0226]).
Accordingly, in light of Applicant’s specification, the claimed terms of apparatus gas flow rate with a time-varying flow rate, a composite gas outflow from a patient, a leak gas flow, and an exhaled gas flow are reasonably construed as a generic respiratory flow device and components therein. It is clear, from the claims themselves and the specification, that these limitations require no improved resources, just already available respiratory flow devices, with their already available basic functions, to use as tools in executing the claimed process.
The recitation of the above-identified additional limitations in claims 10-27 amounts to mere instructions to implement the abstract idea on a computer and/or generic respiratory flow device. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer or generic respiratory flow device, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the methods of claims 10-27 are directed to applying an abstract idea (e.g., mental process or certain method of organizing human activity) on a general purpose computer and/or generic respiratory flow device without (i) improving the performance of the computer and/or generic respiratory flow device itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of claims 10-27 provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent claim 10 (and its dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, claims 10-27 merely apply an abstract idea to a computer and/or generic respiratory flow device and do not (i) improve the performance of the computer and/or generic respiratory flow device itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the claims 10-27 amounts to significantly more than the abstract idea itself.
Accordingly, claims 10-27 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
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 10-27 are rejected under 35 U.S.C. 103 as being unpatentable over Evans et al. (US 20170281051 A1; hereinafter “Evans”).
Regarding claim 10, Evans discloses a method of determining a parameter (concentration) of a gas (gas of interest; [0098], lines 9-10) present in an exhaled gas flow ([0098], lines 9-17) comprising:
providing an apparatus gas flow (gases supplied or provided to an interface or via a system; [0069], line 3) with a time-varying flow rate to a patient ([0069], lines 2-4, where the cannula supplies the flow of gas to the patient),
determining a parameter (concentration) of a gas (gas of interest; [0098], lines 9-10) present in a composite gas outflow from the patient (total expiratory flow, [0099], lines 9-11), the composite gas outflow comprising:
leak gas flow from the apparatus gas flow (leak cannula flow, [0098], lines 4-8, where the cannula is a non-sealing patient interface, hence gas flow will leak during use and a leak gas flow will be present), and
exhaled gas flow from a patient (expiratory flow from the lungs of a patient, [0098], lines 4-7) with the gas present (gas of interest; [0098], lines 9-10),
and
determining the parameter (concentration) of the gas (gas of interest; [0098], lines 9-10) present in the exhaled gas flow ([0098], lines 12-13) based on the determined parameter of the gas (gas of interest; [0098], lines 9-10) present in the composite gas outflow and the time-varying flow rate at the two time points, and ([0069], lines 2-4; [0098], lines 12-17, where cannula flow is the flow of gas supplied by the apparatus; [0099] and [0104], where flow rate is measured with an optical flow sensor, hence measurements are inherently taken at two time points)
providing an output comprising an indication related to the parameter of the gas present in the exhaled gas flow ([0221] and [0223]).
While Evans does disclose a capnograph to measure a concentration of a gas of interest in a total expiratory flow ([0099], lines 9-11) and an optical flow sensor to measure various flow rates ([0104]-[0105]), Evans fails to explicitly disclose determining the concentration of a gas present in a composite gas outflow at two time points.
However, it is well-understood by one of ordinary skill in the art that a capnograph provides continuous, real-time monitoring and measurements.
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 Evans to determine a concentration of a gas present in a total expiratory flow at two time points using a capnograph ([0099], lines 9-11; [0098]), such that the two time points the capnograph measures the concentration of the gas present in the total expiratory flow aligns with the two time points the optical flow meter measures a flow rate of the expiratory flow rate and the cannula flow rate (Fig. 4; [0104]-[0105]) to improve the sampling rate of the sensor ([0100]) and increase the system’s accuracy and subsequent determinations/calculations when experiencing fluctuating flow rates ([0102], lines 1-6).
Regarding claim 11, Evans as modified teaches the invention as set forth in claim 10, wherein the apparatus gas flow (gases supplied or provided to an interface or via a system; [0069], line 3) with the time-varying flow rate ([0069], lines 2-4, where the cannula supplies the flow of gas to the patient) comprises at least a first flow rate at a first time of the two time points (first cannula flow rate at a first time, measured by optical flow meter at a t1, see claim 10 above; [0102], lines 1-6; [0105], lines 1-7) and a second flow rate at a second time of the two time points (second cannula flow rate at a second time, measure by optical flow meter and a t2, see claim 10 above; [0102], lines 1-6; [0105], lines 1-7), and
wherein the method further comprises:
determining the parameter (concentration) of the gas (gas of interest; [0098], lines 9-10) present in the exhaled gas flow ([0098], lines 12-13) comprises using the determined parameter (concentration) of the gas (gas of interest; [0098], lines 9-10) present in the composite gas outflow (total expiratory flow, [0099], lines 9-11) determined at the first flow rate (first cannula flow rate used to determine concentration of gas of interest in total expiratory flow; [0046], lines 7-10; step 402, step 404, [0105], lines 1-7; [0099], lines 9-11) and determined at the second flow rate (second cannula flow rate used to determine concentration of gas of interest in total expiratory flow; [0046], lines 10-14; step 402, step 404, [0105], lines 1-7; [0099], lines 9-11).
Regarding claim 12, Evans as modified teaches the invention as set forth in claim 10, wherein the parameter (concentration) comprises a fraction of the gas (gas of interest; [0098], lines 9-10) present in the exhaled gas flow (it is inherent that a concentration of a gas of interest present in an exhaled gas flow would comprise a fraction of the gas of interest present in the exhaled gas flow as a concentration of a gas is a measurement of a part of a whole which refers to the amount of a gas in a given volume of air, typically referred to with units of parts per million or grams per cubic meter, and a fraction of a gas also is a measurement of a part of a whole which refers to a proportion of a gas in the air, typically referred to with a decimal or percentage).
Regarding claim 13, Evans as modified teaches the invention as set forth in claim 10, wherein the gas (gas of interest; [0098], lines 9-10) present is:
CO2 ([0098], lines 9-10),
O2 ([0098], lines 9-10),
Nitrogen ([0009], lines 7-10),
Helium, and/or
anaesthetic agent ([0009], lines 7-10).
Regarding claim 14, Evans as modified teaches the invention as set forth in claim 10, wherein the parameter (concentration) of the gas (gas of interest; [0098], lines 9-10) present in the composite gas outflow (total expiratory flow, [0099], lines 9-11) is determined during an inspiration phase and/or an expiration phase of the patient ([0098], lines 3-4).
Regarding claim 15, Evans as modified teaches the invention as set forth in claim 10, wherein the parameter of the gas (gas of interest; [0098], lines 9-10) present in the exhaled gas flow is a gas fraction (concentration, see claim 12); and wherein the method further comprises:
determining the gas fraction of the gas present (FE) in the exhaled as flow (concentration of the gas of interest present in an exhaled gas flow, Cp; [0114]-[0123]) using the determined parameter of gas present in the composite gas outflow and the time-varying flow rate component ([0114]-[0123]; [0069], lines 2-4; [0098], lines 12-17, where cannula flow is the flow of gas supplied by the apparatus);
Where
FE(t) is a CO2 gas fraction, an O2 gas fraction, or an other gas fraction in the exhaled gas flow (Cp is the exhaled concentration of the gas of interest; [0113], lines 1-2, where the gas of interest is CO2);
Fm(t) is a fraction of the gas (gas of interest; [0098], lines 9-10) present measured in the composite gas outflow at time t (Ce is the concentration of gas interest in the total expiratory flow; [0118], lines 1-2; [0098]; [0099], lines 9-11; see claim 10 above);
Qo(t) is a flow rate of the apparatus gas flow provided to the patient, at time t (QC is the first cannula flow rate at a first time, measured by optical flow meter at a t1, see claim 10 above; [0102], lines 1-6; [0105], lines 1-7; [0106], lines 7-8);
Fm(t+
∆
t) is a fraction of the gas (gas of interest; [0098], lines 9-10) present measured in the composite gas outflow at time t +
∆
t ([0098]; [0099], lines 9-11; see claim 10 above);
Qo(t+
∆
t) is a flow rate of the apparatus gas flow provided to the patient at time t +
∆
t (second cannula flow rate at a second time, measure by optical flow meter and a t2, see claim 10 above; [0102], lines 1-6; [0105], lines 1-7);
Fo(t) is a volume fraction of the gas (gas of interest; [0098], lines 9-10) present in the apparatus gas flow coming from a respiratory apparatus, at time t (Cc is the concentration of the gas of interest in the cannula flow rate from a respiratory apparatus; [0120], lines 1-2)
Fo(t+
∆
t) is a volume fraction of the gas (gas of interest; [0098], lines 9-10) present in the apparatus gas flow coming from the respiratory apparatus, at time t+
∆
t ([0098]; [0099], lines 9-11; [0104]-[0105]; see claim 10 above).
Evans as modified does not explicitly teach further comprising:
determining the gas fraction of the gas present (FE) in the exhaled as flow (concentration of the gas of interest present in an exhaled gas flow, Cp; [0114]-[0123]) using the determined parameter of gas present in the composite gas outflow and the time-varying flow rate component ([0114]-[0123]; [0069], lines 2-4; [0098], lines 12-17, where cannula flow is the flow of gas supplied by the apparatus) comprises using:
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47
675
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However, Evans teaches a function to determining the concentration of the gas of interest present in an exhaled gas flow using the determined concentration of the gas of interest present in the total expiratory gas outflow and the cannula flow rate ([0114]-[0123], where the gas of interest is CO2).
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 discover the optimal workable ranges since the general conditions of the claimed methods are disclosed in the prior art (See MPEP § 2144.05.II.A) and there are a finite number of identified, predictable solutions to calculate a concentration of a gas of interest in the exhaled gas flow from a patient’s lungs when provided the concentration of the gas of interest measured in the total expiratory gas outflow at a given time, the flow rate of the gas being supplied to the patient at a given time, the concentration of the gas of interest measured in the total expiratory gas outflow after a duration of time, the flow rate of the gas being supplied to the patient after a duration of time, the concentration of the gas of interest present in the gas supplied to the patient after at a given time, and the concentration of the gas of interest present in the gas supplied to the patient after a duration of time.
Regarding claim 16, Evans as modified teaches the invention as set forth in claim 10, wherein the parameter of gas (gas of interest; [0098], lines 9-10) present in the exhaled gas flow is a gas fraction (concentration, see claim 12) and determining the gas fraction of the gas present (gas of interest; [0098], lines 9-10) (FE) in the exhaled gas flow (concentration of the gas of interest present in an exhaled gas flow, Cp; [0114]-[0123]) using the determined parameter of gas (concentration of the gas of interest; [0098], lines 9-10) present in the composite gas outflow and the time-varying flow rate component ([0114]-[0123]; [0069], lines 2-4; [0098], lines 12-17, where cannula flow is the flow of gas supplied by the apparatus) comprises determining the gas (gas of interest; [0098], lines 9-10) fraction FE(t) as a function of:
Q
o
t
,
Q
o
t
+
∆
t
,
F
m
t
+
∆
t
,
F
m
(
t
)
(see claim 15)
Where
Fm(t), volume fraction of the gas present (gas of interest; [0098], lines 9-10) measured in the patient composite gas outflow from the patient at time t (Ce is the concentration of gas interest in the total expiratory flow; [0118], lines 1-2; [0098]; [0099], lines 9-11; see claim 10 above);
Fm(t) (Ce is the concentration of gas interest in the total expiratory flow; [0118], lines 1-2; [0098]; [0099], lines 9-11; see claim 10 above) is measured at the mouth of the patient when the patient's mouth is open and/or or the nose if the patient's mouth is closed (sampling adaptor 206 and actual sensor 204 at position 202, see Fig. 2, where position 202 is located between Y-piece 127 and patient interface 126; [0092], lines 11-25);
Qo(t), flow rate of the apparatus gas flow provided from the respiratory apparatus to the patient at time t (Qc is first cannula flow rate at a first time, measured by optical flow meter at a t1, see claim 10 above; [0102], lines 1-6; [0105], lines 1-7);
Fm(t+
∆
t), volume fraction of the gas present (gas of interest; [0098], lines 9-10) measured in the patient composite gas outflow at time t +
∆
t ([0098]; [0099], lines 9-11; see claim 10 above);
Qo(t+
∆
t), flow rate of apparatus gas flow (cannula flow) provided from the respiratory apparatus to the patient, at time t +
∆
t (second cannula flow rate at a second time, measure by optical flow meter and a t2, see claim 10 above; [0102], lines 1-6; [0105], lines 1-7).
Regarding claim 17, Evans et al. discloses the invention as set forth in claim 10, wherein the parameter of the gas (gas of interest; [0098], lines 9-10) present in the exhaled gas flow is a gas fraction (concentration, see claim 12) and determining the gas fraction of the gas present (FE) (gas of interest; [0098], lines 9-10) in the exhaled gas flow (concentration of the gas of interest present in an exhaled gas flow, Cp; [0114]-[0123]) using the determined parameter of the gas (concentration of the gas of interest; [0098], lines 9-10) present in the composite gas outflow and the time-varying flow rate component ([0114]-[0123]; [0069], lines 2-4; [0098], lines 12-17, where cannula flow is the flow of gas supplied by the apparatus):
Where
FE(t) is a CO2 and/or O2 concentration in the exhaled gas flow (Cp is the exhaled concentration of CO2; [0113], lines 1-2);
Fm(t) is a fraction of CO2 measured in the composite gas outflow at time t (Ce is the concentration of CO2 in the total expiratory flow; [0118], lines 1-2, where the concentration of CO2 is measured at a first time, see claim 10 above; [0098]; [0099], lines 9-11);
Qo(t) is a flow rate of the apparatus gas flow provided to the patient at time t (Qc is the first cannula flow rate at a first time, measured by optical flow meter at a t1, see claim 10 above; [0102], lines 1-6; [0105], lines 1-7; [0106], lines 7-8);
Fm(t+
∆
t) is a fraction of CO2 measured in the composite gas outflow at time t +
∆
t ([0098]; [0099], lines 9-11; see claim 10 above);
Qo(t+
∆
t) is a flow rate of the apparatus gas flow provided to the patient at time t +
∆
t (second cannula flow rate at a second time, measure by optical flow meter and a t2, see claim 10 above; [0102], lines 1-6; [0105], lines 1-7).
Evans as modified does not explicitly teach determining the gas fraction of the gas present (FE) (gas of interest; [0098], lines 9-10) in the exhaled gas flow (concentration of the gas of interest present in an exhaled gas flow, Cp; [0114]-[0123]) using the determined parameter of the gas (concentration of the gas of interest; [0098], lines 9-10) present in the composite gas outflow and the time-varying flow rate component ([0114]-[0123]; [0069], lines 2-4; [0098], lines 12-17, where cannula flow is the flow of gas supplied by the apparatus) comprises using:
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570
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Greyscale
However, Evans does disclose a function to determining the concentration of the gas of interest present in an exhaled gas flow using the determined concentration of the gas of interest present in the total expiratory gas outflow and the cannula flow rate ([0114]-[0123], where the gas of interest is CO2).
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 discover the optimal workable ranges since the general conditions of the claimed methods are disclosed in the prior art (See MPEP § 2144.05.II.A) and there are a finite number of identified, predictable solutions to calculate a concentration of CO2 in the exhaled gas flow from a patient’s lungs when provided the concentration CO2 measured in the total expiratory gas outflow at a given time, the flow rate of the gas being supplied to the patient at a given time, the concentration of CO2 measured in the total expiratory gas outflow after a duration of time, the flow rate of the gas being supplied to the patient after a duration of time, the concentration of CO2 present in the gas supplied to the patient after at a given time, and the concentration of CO2 present in the gas supplied to the patient after a duration of time.
Regarding claim 18, Evans as modified teaches the invention as set forth in claim 10, wherein the parameter (concentration) of the gas (gas of interest; [0098], lines 9-10) present in the composite gas outflow from the patient (total expiratory flow, [0099], lines 9-11) is measured at or near a mouth and/or a nose of the patient (sampling adaptor 206 and actual sensor 204 at position 202, see Fig. 2, where position 202 is located between Y-piece 127 and patient interface 126; [0092], lines 11-25).
Regarding claim 19, Evans as modified teaches the invention as set forth in claim 11, wherein the first flow rate (first cannula flow rate at a first time, measured by optical flow meter at a t1, see claim 10 above; [0102], lines 1-6; [0105], lines 1-7) and second flow rate (second cannula flow rate at a second time, measure by optical flow meter and a t2, see claim 10 above; [0102], lines 1-6; [0105], lines 1-7) are different flow rates (cannula flow rate is in flux, hence the cannula flow rate measured at t1 is a different flow rate from the cannula flow rate measured at t2; Examiner’s Note: interpretation of “different flow rates” based on Applicant’s specification [0250], [0285], and [0335], see US PGPub 20230116240 A1).
Regarding claim 20, Evans as modified teaches the invention as set forth in claim 11, wherein the first flow rate (first cannula flow rate at a first time, measured by optical flow meter at a t1, see claim 10 above; [0102], lines 1-6; [0105], lines 1-7) and second flow rate (second cannula flow rate at a second time, measure by optical flow meter and a t2, see claim 10 above; [0102], lines 1-6; [0105], lines 1-7) are high flow rates (cannula flow delivered to patient is high flow; [0075], lines 7-12).
Regarding claim 21, Evans as modified teaches the invention as set forth in claim 11, wherein the first flow rate (first cannula flow rate at a first time, measured by optical flow meter at a t1, see claim 10 above; [0102], lines 1-6; [0105], lines 1-7) and second flow rate (second cannula flow rate at a second time, measure by optical flow meter and a t2, see claim 10 above; [0102], lines 1-6; [0105], lines 1-7) are greater than or equal to about 20 L per minute ([0069], lines 1-9, where the first cannula flow rate and second cannula flow rate are gases being supplied to the patient via a cannula; [0007], lines 9-10).
Regarding claim 22, Evans as modified teaches the invention as set forth in claim 10, but fails to explicitly disclose the time-varying flow rate component ([0069], lines 2-4, where the cannula supplies the flow of gas to the patient) is an oscillation with a varying flow rate of greater than or equal to about 20 L per minute.
However, Evans does teach the cannula flow rate could be altered during expiration to provide a lower flow rate ([0234], lines 5-7). Evans further teaches this idea could be extended to techniques that alter the cannula flow from a constant high flow, such as oscillatory flow ([0234], lines 8-11).
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 Evans et al. such that the time-varying flow rate ([0069], lines 2-4, where the cannula supplies the flow of gas to the patient) is an oscillation with a varying flow rate ([0234], lines 5-11) of greater than or equal to about 20 L per minute ([0069], lines 1-9) to more easily detect the concentration of the gas of interest ([0234], lines 3-7).
Regarding claim 23, Evans as modified teaches the invention as set forth in claim 10, comprising providing the apparatus gas flow (gases supplied or provided to an interface or via a system; [0069], line 3) during an anaesthetic procedure ([0225], lines 1-3).
Regarding claim 24, Evans as modified teaches the invention as set forth in claim 10, wherein the apparatus gas flow (gases supplied or provided to an interface or via a system; [0069], line 3) is provided via a non-sealing patient interface ([0030], lines 1-3; nasal cannula, [0086], lines 12-16; nasal cannula provides a flow rate to the patient, [0027], lines 11-12).
Regarding claim 25, Evans as modified teaches the invention as set forth in claim 10, where the apparatus gas flow (gases supplied or provided to an interface or via a system; [0069], line 3) is a high flow gas flow (cannula flow delivered to patient is high flow; [0075], lines 7-12).
Regarding claim 26, Evans as modified teaches the invention as set forth in claim 10, further comprising humidifying the apparatus gas flow ([0069], lines 9-12; [0088], lines 1-6; Fig. 1).
Regarding claim 27, Evans as modified teaches the invention as set forth in claim 10, wherein determining the parameter (concentration) of the gas (gas of interest; [0098], lines 9-10) present in the exhaled gas flow ([0098], lines 12-13) using the determined parameter of the gas (gas of interest; [0098], lines 9-10) present in the composite gas outflow ([0069], lines 2-4; [0098], lines 12-17) comprises measuring only one gas ([0098], lines 12-17, where the gas of interest is only one gas, [0009], lines 7-10) and only the time-varying parameter ([0098], lines 4-9), where the time-varying parameter is a flow rate ([0069], lines 2-4, where the cannula supplies the flow of gas to the patient; [0098], lines 4-9), as best understood by the Examiner (see interpretation of claim 27 in 112(b) rejection of claim 27 above).
Response to Arguments
Applicant’s arguments with respect to claims 10 and 11 have been considered but are moot because the amendments to claim 10 necessitate new ground(s) of rejection.
On pages 8-9 of the Remarks (filed 02/23/2026), Applicant argues Evans (US 20170281051 A1) fails to disclose, teach, or suggest determining the gas present in the exhaled flow based on (1) a determination of the parameter in a composite gas outflow at two time points, as well as (2) “the time-varying flow rate at the two time points”. However, Evans teaches an optical flow meter to measure a time-varying flow rate supplied to a patient, where the optical sensor inherently measures the time-varying flow rate at two time points to track a motion of the flow, and a capnograph to provide continuous, real-time measurements of a concentration of the gas present in the exhaled flow. As such, it would be obvious to one of ordinary skill in the art to modify Evans, such that the capnograph provides measurements of the concentration of the gas present in the exhaled flow at the same two time points the optical flow meter measures the time-varying flow rate supplied to the patient, so the measured values are more accurately represent the system under fluctuating flow, and to improve accuracy of subsequent determinations and/or calculations of the system when experiencing fluctuating flow rates (see 103 rejection of claim 10 above).
On pages 9-10 of the Remarks, Applicant argues Evans fails to disclose, teach, or suggest “the time-varying flow rate comprises at least a first flow rate at a first time of the two time points and a second flow rate at a second time of the two time points”, and “using the determine parameter of the gas present in the composite gas outflow determined at the first flow rate and determined at the second flow rate”, as recited in amended claim 11. However, for at least the same reasons as above, Evans does teach the time-varying flow rate comprises at least a first flow rate at a first time of the two time points and a second flow rate at a second time of the two time points”, and “using the determine parameter of the gas present in the composite gas outflow determined at the first flow rate and determined at the second flow rate” (see 103 rejection of claim 11 above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Klein (WO 2012139204 A1): Regarding measuring a flow rate and a flow volume at two time points to use in gas parameter calculations.
Jafri & Fiedler (EP 3108920 A1): Regarding supplying a gaseous mixture at different time points or at a high dose and a low dose, wherein the high dose and the low dose are supplied at different times.
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.
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/ABIGAYLE DALE/Examiner, Art Unit 3785 /BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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