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 Preliminary Amendment
This office action is in response to the preliminary amendments filed on 02/22/2023. Per the preliminary amendment, claims 1-9 are canceled, claims 10-27 are as currently amended, and claims 28-57 are canceled. Claims 10-27 are pending in the instant application. The amendment to the specification has been accepted and is included in the instant application.
Claim Objections
Claims 10, 13-17, and 19-21 are objected to because of the following informalities:
Claim 10, lines 6-7: “leak gas flow from apparatus gas flow, and exhaled gas flow from a patient with the gas” should read “leak gas flow from the apparatus gas flow, and exhaled gas flow from the patient with the gas present” for consistency and clarity.
Claim 13, line 8: “and/or” should be deleted.
Claim 14, lines 2-3: “during an inspiration and/or expiration phase” should read “during an inspiration and/or an expiration phase” for clarity.
Claim 15, line 4: “determining the fraction of the gas (FE) present in an exhaled gas flow” should read “the gas fraction of the gas present (FE) in the exhaled gas flow” for consistency and clarity.
Claim 15, line 9: “a CO2 or a O2 or an other gas fraction” should read “a CO2 gas fraction or an O2 gas fraction or an other gas fraction” for clarity.
Claim 15, line 23: “outflow at time t +
∆
t” should read “outflow at time t” for consistency.
Claim 16, lines 2-4: “wherein the parameter of gas present in the exhaled gas flow is gas fraction and determining the fraction of the gas (FE) present in an exhaled gas flow using the determined parameter of gas present in the composite gas outflow” should read “wherein the parameter of the gas present in the exhaled gas flow is gas fraction and determining the gas fraction of the gas present (FE) in the exhaled gas flow using the determined parameter of the gas present in the composite gas outflow” for consistency and clarity.
Claim 16, line 8: “of the gas component in the patient composite gas outflow” should read “of the gas present component in the composite gas outflow” for consistency.
Claim 16, line 11-12: “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” should read “measured at a mouth of the patient when the patient's mouth is open and/or or a nose if the patient's mouth is closed” clarity and to establish antecedent basis.
Claim 16, line 13: “from the respiratory apparatus” should read “from a respiratory apparatus” to establish antecedent basis.
Claim 16, line 15: “of the gas component measured in the patient composite gas” should read “of the gas present measured in the composite gas” for consistency.
Claim 16, line 19: “flow rate of apparatus gas flow” should read “flow rate of the apparatus gas flow” for consistency and clarity.
Claim 17, line 3: “the gas fraction (FE) in the exhaled gas flow” should read “the gas fraction of the gas present (FE) in the exhaled gas flow” for consistency and clarity.
Claim 19, line 2: “the first and second flow rates are different flow rates” should read “the first flow rate and the second flow rate are different flow rates” for consistency and clarity.
Claim 20, line 2: “the first and second flow rates are high flow rates” should read “the first flow rate and the second flow rate are high flow rates” for consistency and clarity.
Claim 21, line 2: “the first and second flow rates” should read “the first flow rate and the second flow rate” for consistency and 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 21, 22, and 27 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.
The term “about” in claim 21 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the range of flow rates for which the first and second flow must be greater than or equal to is indefinite due to the use of the term “about” in line 2.
The term “about” in claim 22 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the range of flow rates for which the time-varying flow rate must be greater than or equal to is indefinite due to the use of the term “about” in line 3.
Claim 27 recites the limitation " the time-varying parameter, the time-varying parameter being a flow rate" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the time-varying parameter is the time-varying flow rate disclosed in claim 10, or if applicant is attempting to recite a new limitation. For the purpose of examination, the above limitation will be interpreted as – the time varying flow rate, the time-varying flow rate being a 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 an abstract idea without significantly more. The claims recite a method.
Regarding claim 10, the claim recites determining a parameter of a gas present in an exhaled gas flow, determining a parameter of the gas present in a composite gas outflow from the patient, and determining the parameter of the gas present in the exhaled gas flow using the determined parameter of the gas present in the composite gas outflow and the time-varying flow rate.
The limitation “determining a parameter of a gas present in an exhaled gas flow”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process). For example, “determining” in the context of this claim encompasses the user manually calculating the parameter of a gas present in an exhaled gas flow.
Similarly, the limitation “determining a parameter of the gas present in a composite gas outflow from the patient”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process. For example, “determining” in the context of this claim encompasses the user manually calculating the parameter of the gas present in a composite gas outflow from the patient.
Similarly, the limitation “determining the parameter of the gas present in the exhaled gas flow using the determined parameter of the gas present in the composite gas outflow and the time-varying flow rate”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process. For example, “determining” in the context of this claim encompasses the user manually calculating the parameter of the gas present in the exhaled gas flow using the determined parameter of the gas present in the composite gas outflow and the time-varying flow rate.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites one additional element – providing an apparatus gas flow with a time-varying flow rate to a patient. The apparatus flow rate is recited at a high-level of generality (i.e., as a generic apparatus flow rate provided to the patient) such that it amounts to no more than a mere insignificant extra solution activity of mere instructions to apply the exception using a generic structure or component. Accordingly, this additional element does not integrate the abstract idea into a practical application it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of providing an apparatus gas flow with a time-varying flow rate to a patient amount to no more than a mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component. Tatkov et al. (US 20150128942 A1) discloses the supply of an apparatus gas flow with a time-varying flow rate ([0068], lines 1-5; [0084], lines 9-12; [0093], lines 14-18). Therefore, the instantly claimed additional element is well-understood, routine, and conventional. In other words, the additional element amounts to no more than a mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component. A mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component cannot provide an inventive concept. The claim is not patent eligible.
Regarding claim 15, the claim recites determining the fraction of the gas (FE) present in an exhaled gas flow using he determined parameter of gas present in the composite gas outflow and the time-varying flow rate using:
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The limitation “determining the fraction of the gas (FE) present in an exhaled gas flow using he determined parameter of gas present in the composite gas outflow and the time-varying flow rate”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process. For example, “determining” in the context of this claim encompasses the user manually calculating the fraction of the gas (FE) present in an exhaled gas flow using the determined parameter of gas present in the composite gas outflow and the time-varying flow rate utilizing the equation recited above.
If a claim limitation, under its broadest reasonable interpretation, covers mathematical relationships, mathematical formulas or equations, mathematical calculations, then it falls within the “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim, as a whole, only recites one additional element – providing an apparatus gas flow with a time-varying flow rate to a patient. The apparatus flow rate is recited at a high-level of generality (i.e., as a generic apparatus flow rate provided to the patient) such that it amounts to no more than a mere insignificant extra solution activity of mere instructions to apply the exception using a generic structure or component. Accordingly, this additional element does not integrate the abstract idea into a practical application it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim, as a whole, does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of providing an apparatus gas flow with a time-varying flow rate to a patient amount to no more than a mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component. Tatkov et al. (US 20150128942 A1) discloses the supply of an apparatus gas flow with a time-varying flow rate ([0068], lines 1-5; [0084], lines 9-12; [0093], lines 14-18). Therefore, the instantly claimed additional element is well-understood, routine, and conventional. In other words, the additional element amounts to no more than a mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component. A mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component cannot provide an inventive concept. The claim is not patent eligible
Regarding claim 16, the claim recites determining the fraction of the gas (FE) present in an exhaled gas flow using the determined parameter of gas present in the composite gas outflow and the time-varying flow rate comprises determining the gas fraction FE(t) as a function of:
Q
o
t
,
Q
o
t
+
∆
t
,
F
m
t
+
∆
t
,
F
m
(
t
)
The limitation “determining the fraction of the gas (FE) present in an exhaled gas flow using the determined parameter of gas present in the composite gas outflow and the time-varying flow rate”, as drafted, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process. For example, “determining” in the context of this claim encompasses the user manually calculating the fraction of the gas (FE) of the gas present in the exhaled gas flow using the determined parameter of the gas present in the composite gas outflow and the time-varying flow rate.
Similarly, the limitation “determining the gas fraction FE(t) as a function of
Q
o
t
,
Q
o
t
+
∆
t
,
F
m
t
+
∆
t
,
F
m
(
t
)
”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process. For example, “determining” in the context of this claim encompasses the user manually calculating the gas fraction FE(t) as a function of
Q
o
t
,
Q
o
t
+
∆
t
,
F
m
t
+
∆
t
,
F
m
(
t
)
.
If a claim limitation, under its broadest reasonable interpretation, covers mathematical relationships, mathematical formulas or equations, mathematical calculations, then it falls within the “Mathematical Concepts” grouping of abstract ideas. Further, if a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim, as a whole, only recites one additional element – providing an apparatus gas flow with a time-varying flow rate to a patient. The apparatus flow rate is recited at a high-level of generality (i.e., as a generic apparatus flow rate provided to the patient) such that it amounts to no more than a mere insignificant extra solution activity of mere instructions to apply the exception using a generic structure or component. Accordingly, this additional element does not integrate the abstract idea into a practical application it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim, as a whole, does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of providing an apparatus gas flow with a time-varying flow rate to a patient amount to no more than a mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component. Tatkov et al. (US 20150128942 A1) discloses the supply of an apparatus gas flow with a time-varying flow rate ([0068], lines 1-5; [0084], lines 9-12; [0093], lines 14-18). Therefore, the instantly claimed additional element is well-understood, routine, and conventional. In other words, the additional element amounts to no more than a mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component. A mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component cannot provide an inventive concept. The claim is not patent eligible.
Regarding claim 17, the claim recites determining the gas fraction (FE) in the exhaled gas flow using the determined parameter of the gas present in the composite gas outflow and the time-varying flow rate using:
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61
570
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The limitation “determining the gas fraction (FE) in the exhaled gas flow using the determined parameter of the gas present in the composite gas outflow and the time-varying flow rate” using the equation above, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process. For example, “determining” in the context of this claim encompasses the user manually calculating the gas fraction (FE) in the exhaled gas flow using the determined parameter of the gas present in the composite gas outflow and the time-varying flow rate utilizing the equation recited above.
If a claim limitation, under its broadest reasonable interpretation, covers mathematical relationships, mathematical formulas or equations, mathematical calculations, then it falls within the “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim, as a whole, only recites one additional element – providing an apparatus gas flow with a time-varying flow rate to a patient. The apparatus flow rate is recited at a high-level of generality (i.e., as a generic apparatus flow rate provided to the patient) such that it amounts to no more than a mere insignificant extra solution activity of mere instructions to apply the exception using a generic structure or component. Accordingly, this additional element does not integrate the abstract idea into a practical application it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim, as a whole, does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of providing an apparatus gas flow with a time-varying flow rate to a patient amount to no more than a mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component. Tatkov et al. (US 20150128942 A1) discloses the supply of an apparatus gas flow with a time-varying flow rate ([0068], lines 1-5; [0084], lines 9-12; [0093], lines 14-18). Therefore, the instantly claimed additional element is well-understood, routine, and conventional. In other words, the additional element amounts to no more than a mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component. A mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component cannot provide an inventive concept. The claim is not patent eligible
In regards to claims 11-14 and 18-27, the claimed invention further describes the judicial exception in detail without however integrating said judicial exception into a practical application and/or providing additional elements that are sufficient to amount to significantly more than the judicial exception for reasons provided supra.
Claim Rejections - 35 USC § 102
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 10-14, 18-21, and 23-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evans et al. (US 20170281051 A1).
Regarding claim 10, Evans et al. 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 the 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 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 (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) using 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 ([0069], lines 2-4; [0098], lines 12-17, where cannula flow is the flow of gas supplied by the apparatus).
Regarding claim 11, Evans et al. discloses 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 (first cannula flow rate at a first time; [0046], lines 7-10, where a first instantaneous flow rate is measured at a first time; step 402, where an instantaneous flow rate is measured, and step 404, where the method of step 402 can be used to determine an instantaneous cannula flow rate at a first time; [0105], lines 1-7) and a second flow rate at a second time (second cannula flow rate at a second time; [0046], lines 10-14, where a second instantaneous flow rate is measured at a second time; step 402, where an instantaneous flow rate is measured, and step 404, where the method of step 402 can be used to determine an instantaneous cannula flow rate at a second time; [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) using 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 ([0069], lines 2-4; [0098], lines 12-17, where cannula flow is the flow of gas supplied by the apparatus) 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 et al. discloses 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 et al. discloses 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 et al. discloses 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 and/or expiration phase of the patient ([0098], lines 3-4).
Regarding claim 18, Evans et al. discloses 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 et al. discloses the invention as set forth in claim 11, wherein the first (first cannula flow rate at a first time; [0046], lines 7-10; step 402, step 404, [0105], lines 1-7) and second flow rates (second cannula flow rate at a second time; [0046], lines 10-14; step 402, step 404, [0105], lines 1-7) are different flow rates (the first cannula flow rate is the instantaneous patient expiratory flow measured at a first time, the second cannula flow rate is the instantaneous patient expiratory flow measured at a second time, hence the first cannula flow rate and the second cannula flow rate are not the same and must be two different flow rates).
Regarding claim 20, Evans et al. discloses the invention as set forth in claim 11, wherein the first (first cannula flow rate, see claim 11) and second flow rates (second cannula flow rate, see claim 11) are high flow rates (cannula flow delivered to patient is high flow; [0075], lines 7-12).
Regarding claim 21, Evans et al. discloses the invention as set forth in claim 11, wherein the first (first cannula flow rate, see claim 11) and second flow rates (second cannula flow rate, see claim 11) 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 23, Evans et al. discloses 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 et al. discloses 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 et al. discloses 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 et al. discloses 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 et al. discloses 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), the time-varying parameter being a flow rate ([0069], lines 2-4, where the cannula supplies the flow of gas to the patient; [0098], liens 4-9).
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 15-17 and 22 is rejected under 35 U.S.C. 103 as being unpatentable over Evans et al. (US 20170281051 A1).
Regarding claim 15, 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 wherein the method further comprises:
determining the fraction of the gas (FE) present in an exhaled gas 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 ([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 or a O2 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, where the gas of interest is CO2 and the concentration of CO2 is measured at a first time, see claims 11 and 15);
Qo(t) is a flow rate of the apparatus gas flow provided to the patient, at time t (QC is the first instantaneous cannula flow rate measured at a first time; [0106], lines 7-8; see claim 11);
Qo(t+
∆
t) is a flow rate of the apparatus gas flow provided to the patient at time t +
∆
t (second instantaneous cannula flow rate measured at a second time, see claim 11);
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).
Evans et al. does not explicitly disclose further comprising:
determining the fraction of the gas (FE) present in an exhaled gas 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 ([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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Where
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;
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.
However, Evans et al. does disclose a first sensor configured to measure a concentration of a gas of interest in a total expiratory flow ([0025], lines 3-4), where the flow rate of the total expiratory flow is an instantaneous total expiratory flow rate measured at a first time and a second time ([0046], lines 5-14). Hence, the measurement of the concentration of the gas of interest in the total expiratory flow must be measured at a corresponding first time and second time to the first time and second time measurements of the instantaneous total expiratory flow rates to calculate the concentration of the gas of interest at a given time with a given measured flow rate ([0114]-[0119]). Further, Evans et al. discloses the measurement of the concentration of the gas of interest in cannula flow rate ([0028], lines 8-9), where the cannula flow rate is an instantaneous flow rate measured at a first time and a second time (see claim 11). Hence, the measurement of the concentration of the gas of interest in the cannula flow rate must be measured at a corresponding first time and second time respectively to the first time and second time measurements of the instantaneous cannula flow rate to calculate the flow of the gas of interest, and the concentration of the gas of interest, present in the cannula flow at a given time ([0114]; [0116]-[0121]). Additionally, Evans et al. 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 further modify Evans et al. such that:
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 (Ce measured at a second time; [0046], lines 5-14; [0114]-[0119], where the concentration of the gas of interest in the total expiratory gas outflow is measured at a respective corresponding first time and second time to the first time and second time measurements of the instantaneous total expiratory flow rates);
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 (Cc measured at a second time; [0028], lines 8-9; [0114]; [0116]-[0121], where the concentration of the gas of interest present in the cannula flow is measured at a respective corresponding first time and second time to the first time and second time measurements of the instantaneous cannula flow rates; see claim 11).
Furthermore, 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 et al. discloses 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 gas fraction (concentration, see claim 12) and determining the fraction of the gas (gas of interest; [0098], lines 9-10) (FE) present in an 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 ([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 (gas of interest; [0098], lines 9-10) component 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, where the gas of interest is CO2 and the concentration of CO2 is measured at a first time, see claims 11 and 15);
Fm(t) (Ce is the concentration of gas interest in the total expiratory flow; [0118], lines 1-2, where the gas of interest is CO2 and the concentration of CO2 is measured at a first time, see claims 11 and 15) is preferably 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 the first instantaneous cannula flow rate measured at a first time; [0106], lines 7-8; see claim 11);
Fm(t+
∆
t), volume fraction of the gas (gas of interest; [0098], lines 9-10) component measured in the patient composite gas outflow at time t +
∆
t (Ce measured at a second time; [0046], lines 5-14; [0114]-[0119], where the concentration of the gas of interest in the total expiratory gas outflow is measured at a respective corresponding first time and second time to the first time and second time measurements of the instantaneous total expiratory flow rates, see claim 15);
Qo(t+
∆
t), flow rate of apparatus gas flow (cannula flow) provided from the respiratory apparatus to the patient, at time t +
∆
t (second instantaneous cannula flow rate measured at a second time, see claims 11 and 15).
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 (gas of interest; [0098], lines 9-10) fraction (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 the gas (concentration of the gas of interest; [0098], lines 9-10) present in the composite gas outflow and the time-varying flow rate ([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 claims 11 and 15);
Qo(t) is a flow rate of the apparatus gas flow provided to the patient at time t (Qc is the first instantaneous cannula flow rate measured at a first time; [0106], lines 7-8; see claim 11);
Fm(t+
∆
t) is a fraction of CO2 measured in the composite gas outflow at time t +
∆
t (Ce measured at a second time; [0046], lines 5-14; [0114]-[0119], where the concentration of the gas of interest in the total expiratory gas outflow is measured at a respective corresponding first time and second time to the first time and second time measurements of the instantaneous total expiratory flow rates);
Qo(t+
∆
t) is a flow rate of the apparatus gas flow provided to the patient at time t +
∆
t (second instantaneous cannula flow rate measured at a second time, see claims 11 and 15).
Evans et al. does not explicitly disclose determining the gas (gas of interest; [0098], lines 9-10) fraction (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 the gas (concentration of the gas of interest; [0098], lines 9-10) present in the composite gas outflow and the time-varying flow rate ([0114]-[0123]; [0069], lines 2-4; [0098], lines 12-17, where cannula flow is the flow of gas supplied by the apparatus) comprises using:
PNG
media_image2.png
61
570
media_image2.png
Greyscale
However, Evans et al. 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 22, Evans et al. discloses the invention as set forth in claim 10, but fails to explicitly disclose 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 of greater than or equal to about 20 L per minute.
However, Evans et al. does disclose the cannula flow rate could be altered during expiration to provide a lower flow rate ([0234], lines 5-7). Evans et al. further discloses 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
White et al. (US 20160193438 A1): Regarding the general inventive concept, including: determining the concentration of a gas of interest, delivered flow to patient with oscillation, measuring the flow of the gas delivered to the patient, and determining the concentration of expired CO2.
Landis et al. (US 20160367779 A1): Regarding a high flow therapy system with a non-sealing patient interface, where the flow rate of the gas delivered to the patient is controlled by a microprocessor, and the concentration of oxygen is determined and monitored.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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