DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/15/2026 has been entered.
Response to Arguments
This office action is in response to the Request for Continued Examination filed on 09/15/2026. As directed by the amendments: claims 1 – 23 are pending, no claims have been cancelled, no claims have been added & claims 1, 7, 18 & 22 have been amended.
Applicant’s arguments with respect to claim(s) 1 – 21 have been considered but are moot because the new ground of rejection does not rely on the primary reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 09/15/2026 have been fully considered but they are not persuasive. The applicant argues the amended limitation to claim 22 is not disclosed by the references. Based on the fact that this was not considered prior, the examiner has examined the amended claims in the current office action.
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 7 – 17 & 21 – 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an Abstract idea without significantly more.
[Step 1]
Regarding claim 7, the claim is a method/process and is one of the four statutory categories.
[Step 2A, Prong one]
The claim recited the following limitations that recite an abstract idea: obtaining, by a processor, information relating to a patient interface pressure and an oxygen input line flow; and determining, by the processor, a total Venturi flow generator flow output based on the patient interface pressure and the oxygen input line flow, wherein the patient interface pressure sensor and the oxygen input line sensor are in communication with a controller, the controller programmed to receive the patient interface pressure and the oxygen input line flow and determine the total flow output from the Venturi flow generator based on the patient interface pressure at the patient interface, the oxygen input line flow, and stored characterization data corresponding to a type of the Venturi flow generator. (judgment or evaluation, which is grouped as mental process under the 2019 PEG) The above limitations are directed to mental processes that can be done by a person simply receiving the information relating to the patient interface pressure and the oxygen input line flow and determine the total Venturi flow generator flow based on the patient interface pressure and the oxygen input line flow.
[Step 2A, Prong Two]
Claim 7 recited the additional elements of: a flow generator, a processor and a controller.
The flow generator is any type of fluid flow control apparatus that can be connected to a patient interface to input a high-pressure oxygen flow into the adapter and output from the adapter a low pressure of oxygen and/or a low pressure of oxygen blended with ambient air. (Paragraph 0030) The recited abstract process does not improve the functioning of the flow generator, or any other technology or technical field. Nor does the above-identified additional element 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 the general function.
The controller receives input from the flow generator and determines the total flow output. Furthermore, the above identified additional element. The controller does not add a meaningful limitation to the abstract idea because it amounts to simply performing basic calculations and outputting said results is considered a well-understood, routine, conventional computer functions. See MPEP 2106.05(d). 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.
The processor receives data and determines based on the data the total flow output. Furthermore, the above identified additional element. The processor does not add a meaningful limitation to the abstract idea because it amounts to simply performing basic calculations and outputting said results is considered a well-understood, routine, conventional computer functions. See MPEP 2106.05(d). 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 7 (and its respective dependent claims) is not integrated into a practical application under the 2019 PEG.
[Step 2B]
The claims do not cite any additional structures that would make it significantly more than judicial exception. The flow generator consist of a controller and processor. This element is conventionally known in the art as shown by Burgess et al. (US 2020/0179629 A1) Paragraph 0103 discloses the well-known controller for managing flow rate of the gas flowing through the flow therapy apparatus as it is delivered to a patient and controlling the motor speed). The use of a generic processor, memory and/or any other general computer components to store information and perform basic calculations and output said results is considered well-understood, routine, conventional computer functions. Se MPEP 2106.05(d).Therefore, in addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is-well-understood or conventional. Se MPEP 2106.05(g). The components found in the claim is-well-known to be conventional in the art.
Further, dependent claims 8 – 9 include limitations that amount to no more than generally linking the use of the abstract idea to specific Venturi flow generator type and algorithm to calculate the total output as they are token additions to the claims that do not alter or affect the process steps are performed.
[Step 1]
Regarding claim 10, the claim is a method/process and is one of the four statutory categories.
[Step 2A, Prong One]
The claim recites the following limitations that recite abstract idea: receiving information relating to a patient interface pressure and an oxygen input line flow, determining a total flow generator flow output, obtaining a leak flow, calculating patient flow by subtracting the leak flow from the total flow output and calculating the patient tidal volume of gas inhaled. (judgment or evaluation and calculation, which is grouped as mental process under the 2019 PEG) The above limitations are directed to mental process that can be done by a person simply by receiving an input of the desired information from the flow generator and conducting basic calculations to determine the patient tidal volume of gas inhaled.
[Step 2A, Prong Two]
Claim 10 recited the additional elements: a flow generator and a processor.
The flow generator is any type of fluid flow control apparatus that can be connected to a patient interface to input a high-pressure oxygen flow into the adapter and output from the adapter a low pressure of oxygen and/or a low pressure of oxygen blended with ambient air. (Paragraph 0030) The recited abstract process does not improve the functioning of the flow generator, or any other technology or technical field. Nor does the above-identified additional element 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 the general function.
The processor receives data and determines based on the data the total flow output. Furthermore, the above identified additional element. The processor does not add a meaningful limitation to the abstract idea because it amounts to simply performing basic calculations and outputting said results is considered a well-understood, routine, conventional computer functions. See MPEP 2106.05(d). 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.
[Step 2B]
The claims do not cite any additional structures that would make it significantly more than judicial exception. The flow generator consist of a controller and processor. This element is conventionally known in the art as shown by Burgess et al. (US 2020/0179629 A1) Paragraph 0103 discloses the well-known controller for managing flow rate of the gas flowing through the flow therapy apparatus as it is delivered to a patient and controlling the motor speed). The use of a generic processor, memory and/or any other general computer components to store information and perform basic calculations and output said results is considered well-understood, routine, conventional computer functions. Se MPEP 2106.05(d).Therefore, in addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is-well-understood or conventional. Se MPEP 2106.05(g). The components found in the claim is-well-known to be conventional in the art.
Further, dependent claims 11 - 17 include limitations that amount to no more than generally linking the use of the abstract idea to determine the flow generator leak flow based on the pause period and a fraction of inhaled oxygen as they are token additions to the claims that do not alter or affect the process steps are performed.
[Step 1]
Regarding claim 10, the claim is a method/process and is one of the four statutory categories.
[Step 2A, Prong One]
The claim recites the following limitations that recite abstract idea: receiving information related to the input and output of the flow generator, determine the total flow generator flow output based on a patient interface pressure and the flow generator input, determine an oxygen leak flow and calculate a percentage of oxygen in a volume of gas inhaled. (judgment or evaluation and calculation, which is grouped as mental process under the 2019 PEG) The above limitations are directed to mental process that can be done by a person simply by receiving an input of the desired information from the flow generator and conducting basic calculations to determine the percentage of oxygen in a volume of gas inhaled.
[Step 2A, Prong Two]
Claim 10 recited the additional elements: a flow generator and a processor.
The flow generator is any type of fluid flow control apparatus that can be connected to a patient interface to input a high-pressure oxygen flow into the adapter and output from the adapter a low pressure of oxygen and/or a low pressure of oxygen blended with ambient air. (Paragraph 0030) The recited abstract process does not improve the functioning of the flow generator, or any other technology or technical field. Nor does the above-identified additional element 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 the general function.
The processor receives data and determines based on the data the total flow output. Furthermore, the above identified additional element. The processor does not add a meaningful limitation to the abstract idea because it amounts to simply performing basic calculations and outputting said results is considered a well-understood, routine, conventional computer functions. See MPEP 2106.05(d). 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.
[Step 2B]
The claims do not cite any additional structures that would make it significantly more than judicial exception. The flow generator consist of a controller and processor. This element is conventionally known in the art as shown by Burgess et al. (US 2020/0179629 A1) Paragraph 0103 discloses the well-known controller for managing flow rate of the gas flowing through the flow therapy apparatus as it is delivered to a patient and controlling the motor speed). The use of a generic processor, memory and/or any other general computer components to store information and perform basic calculations and output said results is considered well-understood, routine, conventional computer functions. Se MPEP 2106.05(d).Therefore, in addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is-well-understood or conventional. Se MPEP 2106.05(g). The components found in the claim is-well-known to be conventional in the art.
Further, dependent claim 22 include limitations that amount to no more than generally linking the use of the abstract idea to determine the oxygen leak flow based on the pause period as token additions to the claims that do not alter or affect the process steps are performed.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1 – 5 & 7 are rejected under 35 U.S.C. 103 as being unpatentable over Westfall et al. (US 20200368482 A1) in view of Barker et al. (WO 2011136664 A1).
Regarding claim 1, A system for determining total flow output from a Venturi flow generator, the system comprising:
the flow generator 15 for connection to a patient interface 12 (Paragraph 0069).
Westfall does not disclose a venturi flow generator.
However, Barker discloses a venturi adapter. (Page 8, lines 24 – 29)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify the flow generator of Westfall to include a venturi adapter as is able to provide oxygen by having the central source to be oxygen or by blending atmospheric air with incoming oxygen from the central source being a venturi. (Page 8, lines 24 – 29)
Modified Westfall discloses the patient interface 12 in communication with a patient interface pressure sensor 36 to measure a patient interface pressure at the patient interface (Paragraph 0080);
an oxygen input line 32 for conveying oxygen from a source of oxygen to the Venturi flow generator (Barker), the oxygen input line 32 comprising an oxygen flow valve 26 for controlling a flow of oxygen from an oxygen source to the Venturi flow generator (Barker) (Paragraph 0072), and an oxygen input line sensor 43 for determining oxygen input line flow (Paragraph 0074); and
wherein the patient interface pressure sensor 36 and the oxygen input line sensor 43 are in communication with a controller 30 (Paragraph 0071 & 0075), the controller 30 programmed to receive the patient interface pressure and the oxygen input line flow and determine the total flow output from the Venturi flow generator (Barker) based on the patient interface pressure at the patient interface and the oxygen input line flow (Paragraph 0077 – 0079), using a pre-stored characterization algorithm specific to a type of the Venturi flow generator (Baker) (Paragraph 0089), the pre-stored characterization algorithm being generated from pre-measured total flow output data collected for the type of the Venturi flow generator (Barker) at multiple combinations of patient interface pressures and oxygen input line flow rates.(Paragraph 0086 & 0088-0090)
Regarding claim 2, Modified Westfall discloses the system as claimed in claim 1.
Modified Westfall discloses wherein the oxygen input line sensor 43 comprises a pressure sensor 36 for measuring oxygen input line pressure and wherein the oxygen input line flow is determined by the oxygen input line pressure. (Paragraph 0074 – 0075)
Regarding claim 3, Modified Westfall discloses the system as claimed in claim 1.
Modified Westfall discloses wherein the oxygen input line sensor 43 comprises an oxygen flowmeter for measuring an oxygen input line flow. (Paragraph 0074 – 0075 / Note: the examiner considers Westfall teaches the device that measures the flow rate of gas using the pressure)
Regarding claim 4, Modified Westfall discloses the system as claimed in claim 1.
Modified Westfall discloses wherein the controller 30 is programmed to determine the total flow output from the Venturi flow generator (Barker) based on the patient interface pressure at the patient interface and the oxygen input line flow. (Paragraph 0074 – 0075)
Regarding claim 5, Modified Westfall discloses the system as claimed in claim 4.
Modified Westfall discloses wherein the controller 30 is programmed with at least one algorithm to calculate total flow output based on known patient pressure at the patient interface and known oxygen input line flow. (Paragraph 0070 / Note: the examiner considers the algorithm to be the process used in calculations)
Regarding claim 7, A method for determining total Venturi flow generator flow output, the method comprising:
obtaining, by a processor, information relating to a patient interface pressure and an oxygen input line flow (Claim 30); and
determining, by the processor, a total flow output based on the patient interface pressure and the oxygen input line flow (Claim 30).
Westfall does not disclose Venturi flow generator.
However, Barker discloses a venturi adapter. (Page 8, lines 24 – 29)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Westfall to include a venturi adapter as is able to provide oxygen by having the central source to be oxygen or by blending atmospheric air with incoming oxygen from the central source being a venturi. (Page 8, lines 24 – 29)
Modified Westfall discloses wherein the patient interface pressure sensor 36 and the oxygen input line sensor 43 are in communication with a controller 30 (Paragraph 0080), the controller 30 programmed to receive the patient interface pressure and the oxygen input line flow and determine the total flow output from the Venturi flow generator (Barker) based on the patient interface pressure at the patient interface, the oxygen input line flow (Paragraph 0077 – 0079), and stored characterization data corresponding to a type of the Venturi flow generator. (Paragraph 0086 – 0089)
Claim(s) 1 – 5 are rejected under 35 U.S.C. 103 as being unpatentable over Westfall et al. (US 20200368482 A1) in view of Barker et al. (WO 2011136664 A1) as claimed in claim 1, in further view Burk et al (US 10737049 B1).
Regarding claim 6, Modified Westfall discloses the system as claimed in claim 1.
Modified Westfall discloses wherein the system further comprises a housing 200, the controller 30, the oxygen flow valve 26, and the patient interface pressure sensor 36 located within the housing 200 (Figure 7), the housing 200 having a coupler 16 to couple to the oxygen source to the housing 200 (Paragraph 0071).
Modified Westfall does not disclose the housing having a receptacle.
Burk discloses the housing 49 have a receptacle 48. (Column 8, Paragraph 2)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Westfall to include wherein the housing has a receptacle as it is a known way of being able to receive the housing of any connector. (Column 8, Paragraph 2)
Modified Westfall discloses wherein the Venturi flow generator (Barker) is coupled to a proximal end of the oxygen input line 32 (Figure 7).
Modified Westfall does not disclose wherein a distal end of the oxygen input line comprises a connector to connect to the receptacle of the housing, the connector comprising a type-identifier, and the receptacle comprising a reader in communication with the controller, the reader to read the type-identifier and convey the type-identifier to the controller.
Burk discloses wherein a distal end of the oxygen input line 20 comprises a connector 10 to connect to the receptacle 48 of the housing 49 (Column 7, Paragraph 1 / Column 8, Paragraph 2), the connector 10 comprising a type-identifier 30 (Column 8, last paragraph), and the receptacle 48 comprising a reader in communication with the controller (Column 9, Paragraph 1 discloses the readers to be optical sensors), the reader to read the type-identifier (Column 10, Paragraph 4) and convey the type-identifier to the controller (Column 10, Paragraph 4).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing day to further modify Westfall to include wherein a distal end of the oxygen input line comprises a connector to connect to the receptacle of the housing, the connector comprising a type-identifier, and the receptacle comprising a reader in communication with the controller, the reader to read the type-identifier and convey the type-identifier to the controller as it would allow the device to receive a signal relating to the patient interface that allows the change of parameters appropriate for the patient interface. (Column 10, Paragraph 4)
Claim(s) 8 – 9 are rejected under 35 U.S.C. 103 as being unpatentable over Westfall et al. (US 20200368482 A1) in view of Barker et al. (WO 2011136664 A1) as claimed in claim 1, in further view Hudson et al (US 2020/0121873 A1).
Regarding claim 8, Modified Westfall discloses the method as claimed in claim 7.
Modified Westfall does not disclose wherein the method further comprises the step of obtaining, by a processor, information relating to a Venturi flow generator type.
Hudson discloses wherein the method further comprises the step of obtaining, by a processor, information relating to a flow generator type (Claim 2)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Westfall to include wherein the method further comprises the step of obtaining, by a processor, information relating to a flow generator type as it would allow selecting a troubleshooting option when something occurs to the device (Claim 5)
Based on this modification, Modified Westfall discloses wherein the step of determining, by the processor, a total Venturi flow generator flow output comprises determining, by the processor, the total Venturi flow generator flow output based on the patient interface pressure, the oxygen input line flow, and the Venturi flow generator type. (as claimed in claim 7)
Regarding claim 9, Modified Westfall discloses the method as claimed in claim 8.
Modified Westfall discloses wherein the processor is programmed with at least one algorithm to calculate the total Venturi flow generator flow output based on known patient interface pressure at the patient interface and known oxygen input line flow. (Paragraph 0086 – 0089)
Claim(s) 10 & 12 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Westfall et al. (US 20200368482 A1) in view of Orr et al. (US 20160166797 A1) & Zilberg et al. (WO 2004/066804 A2).
Regarding claim 10, A system for determining an amount of gas inhaled by a patient, the system comprising:
an air entrainment flow generator 15 for connection to a patient interface 12 (Paragraph 0069);
the patient interface 12 in communication with a patient interface pressure sensor 36 to measure patient interface pressure at the patient interface (Paragraph 0080);
an oxygen input line 32 for conveying oxygen from a source of oxygen to the air entrainment flow generator 15 (Paragraph 0072), the oxygen input line 32 comprising an oxygen flow valve 26 for controlling a flow of oxygen from the source of oxygen to the air entrainment flow generator 15 (Paragraph 0072), and an oxygen input line sensor 43 for determining an oxygen input line flow (Paragraph 0074);
wherein the patient interface pressure sensor 36 and the oxygen input line sensor 43 are in communication with a processor (Paragraph 0092 & Claim 30).
Modified Westfall does not disclose wherein the processor is programmed to receive, during a pause between a patient exhalation and a patient inhalation, the patient pressure at the patient interface and the oxygen input line flow and determine a leak flow output from the air entrainment flow generator based on the patient pressure at the patient interface and the oxygen input line flow during the pause between the patient exhalation and the patient inhalation;
wherein the processor is further programmed to receive, during the patient inhalation, the patient pressure at the patient interface and the oxygen input line flow and determine a total flow output from the air entrainment flow generator based on the patient pressure, the oxygen input line flow, and stored flow generator characteristic information.
Orr discloses wherein the processor 35 is programmed to receive, during a pause between a patient exhalation and a patient inhalation, the patient pressure at the patient interface and the oxygen input line flow (Paragraph 0097) and determine a leak flow (Note: the examiner considers the oxygen leak flow as the flow received in the pause between the inhalation and the exhalation) output from the flow generator based on the patient pressure at the patient interface and the oxygen input line flow during the pause between the patient exhalation and the patient inhalation (Paragraph 0097 discloses calculating the pressure values to determine the baseline pressure of the pause based on the flow of oxygen);
wherein the processor 35 is further programmed to receive, during the patient inhalation, the patient pressure at the patient interface and the oxygen input line flow (Paragraph 0019 – 0023) and determine a total flow output from the flow generator 14 based on the patient pressure at the patient interface and the oxygen input line flow during a patient inhalation (Paragraph 0019 – 0023)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Westfall to include wherein the processor is programmed to receive, during a pause between a patient exhalation and a patient inhalation, the patient pressure at the patient interface and the oxygen input line flow and determine a leak flow output from the air entrainment flow generator based on the patient pressure at the patient interface and the oxygen input line flow during the pause between the patient exhalation and the patient inhalation, wherein the processor is further programmed to receive, during the patient inhalation, the patient pressure at the patient interface and the oxygen input line flow and determine a total flow output from the air entrainment flow generator based on the patient pressure, the oxygen input line flow, and stored flow generator characteristic information as detecting the baseline pressure may be calculated by measuring the pressure at the time between a patient’s breaths i.e., the pause between inspiration and expiration (Paragraph 0097).
Zilberg discloses further programmed to calculate a patient flow (Note: the examiner considers this to be inhalation and exhalation) by subtracting the leak flow output (Note: this is considered to be leak around the patient interface such as a leak around a mask seal) from the total flow output (Note: this is considered the flow that leaves the flow generator). (Claim 4)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Westfall to be programmed to calculate a patient flow by subtracting the leak flow output from the total flow output as it would allow the device to determine when inspiration and expiration begins and determine the flow rates of air to the patient. (Zilberg: Page 2, Paragraph 4)
Regarding claim 12, Modified Westfall discloses the system as claimed in claim 10,
Modified Westfall discloses wherein the oxygen input line sensor 43 for measuring oxygen input line flow is a flow sensor. (Paragraph 0033)
Regarding claim 13, Modified Westfall discloses the system as claimed in claim 10.
Modified Westfall discloses wherein the oxygen input line sensor for measuring oxygen input line flow is an oxygen input line pressure sensor. (Paragraph 0075)
Regarding claim 14, Modified Westfall discloses the system as claimed in claim 10.
Modified Westfall discloses wherein the processor is programmed with at least one algorithm to calculate total flow output based on known patient pressure at the patient interface and known oxygen input line flow. (Paragraph 0032 - 0034 / Note: the examiner considers the algorithm to be the process used in calculations)
Regarding claim 15, Modified Westfall discloses the system as claimed in claim 14.
Modified Westfall discloses wherein the processor is further programmed to calculate a concentration of oxygen in the patient flow to determine a fraction of inhaled oxygen. (Paragraph 0039)
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Westfall et al. (US 20200368482 A1) in view of Orr et al. (US 20160166797 A1) & Zilberg et al. (WO 2004/066804 A2) as claimed in claim 10, in further view of Sackner et al. (WO 9841146 A1).
Regarding claim 11, Modified Westfall discloses the system as claimed in claim 10.
Modified Westfall does not disclose wherein the processor is further programmed to calculate a tidal volume of gas by integrating the patient flow over a single breath.
Sackner discloses wherein the processor is further programmed to calculate a tidal volume of gas by integrating the patient flow over a single breath. (Claim 3)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify Westfall wherein the processor is further programmed to calculate a tidal volume of gas by integrating the patient flow over a single breath as the measurement of breath by breath peak inspiratory flow and acceleration, and breath by breath ventilation as the product of respiratory rate and tidal volume of the breath as herein described, also permit simultaneous computation of the ratio of respiratory drive to ventilation on either a breath by breath or a time average basis. (Column 10, Paragraph 2)
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Westfall et al. (US 20200368482 A1) in view of Orr et al. (US 20160166797 A1) & Zilberg et al. (WO 2004/066804 A2) as claimed in claim 10, in further view of Burk et al (US 10737049 B1).
Regarding claim 16, Modified Westfall discloses the system as claimed in claim 10.
Modified Westfall wherein the system further comprises a housing 200, the processor (Claim 30) , the oxygen flow valve 26, and the patient interface pressure sensor 36 located within the housing 200 (Figure 7), the housing 200 having a coupler 16 to couple to the oxygen source to the housing 200 (Paragraph 0071).
Modified Westfall does not disclose the housing having a receptacle.
Burk discloses the housing 49 have a receptacle 48. (Column 8, Paragraph 2)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Westfall to include wherein the housing has a receptacle as it is a known way of being able to receive the housing of any connector. (Column 8, Paragraph 2)
Modified Westfall discloses wherein the air entrainment flow generator 15 is coupled to a proximal end of the oxygen input line 32 (Figure 7).
Modified Westfall does not disclose wherein a distal end of the oxygen input line comprises a connector to connect to the receptacle of the housing, the connector comprising a type-identifier, and the receptacle comprising a reader in communication with the processor, the reader to read the type-identifier and convey the type-identifier to the processor.
Burk discloses wherein a distal end of the oxygen input line 20 comprises a connector 10 to connect to the receptacle 48 of the housing 49 (Column 7, Paragraph 1 / Column 8, Paragraph 2), the connector 10 comprising a type-identifier 30 (Column 8, last paragraph), and the receptacle 48 comprising a reader in communication with the processor (Column 9, Paragraph 1 discloses the readers to be optical sensors), the reader to read the type-identifier (Column 10, Paragraph 4) and convey the type-identifier to the processor (Column 10, Paragraph 4).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing day to further modify Westfall to include wherein a distal end of the oxygen input line comprises a connector to connect to the receptacle of the housing, the connector comprising a type-identifier, and the receptacle comprising a reader in communication with the controller, the reader to read the type-identifier and convey the type-identifier to the controller as it would allow the device to receive a signal relating to the patient interface that allows the change of parameters appropriate for the patient interface. (Column 10, Paragraph 4)
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Westfall et al. (US 20200368482 A1) in view of Orr et al. (US 20160166797 A1) & Zilberg et al. (WO 2004/066804 A2) as claimed in claim 10, in further view of Hudson et al (US 2020/0121873 A1).
Regarding claim 17, Modified Westfall discloses the system as claimed in claim 10.
Modified Westfall disclose the air entrainment flow generator 15. (as claimed in claim 10)
comprises a type-identifier, and wherein the processor is programmed to receive data relating to the type-identifier of the air entrainment flow generator.
Hudson discloses wherein the flow generator comprises a type-identifier and wherein the processor is programmed to receive data relating to the type-identifier of the air entrainment flow generator. (Claim 2 / Paragraph 0012)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Westfall to include wherein the method further comprises the step of obtaining, by a processor, information relating to a flow generator type as it would allow selecting a troubleshooting option when something occurs to the device (Claim 5 / Paragraph 0012 – 0013)
Claim(s) 18 – 19 & 21 are rejected under 35 U.S.C. 103 as being unpatentable over Westfall et al. (US 20200368482 A1) in view of Zilberg et al. (WO 2004/066804 A2) & Sackner et al. (WO 9841146 A1).
Regarding claim 18, A method for calculating patient tidal volume of gas inhaled, the method comprising:
obtaining, by a processor, information relating to a patient interface pressure and an oxygen input line flow (Claim 30), determining, by the processor (Paragraph 0032 - 0034 / Note: the examiner considers the algorithm to be the process used in calculations), a total flow generator flow output based on the patient interface pressure (Paragraph 0032), the oxygen input line flow 20, and stored flow generator characteristic information (Paragraph 0086 – 0087), wherein oxygen flows from the source of oxygen to the oxygen input line 32, through the oxygen flow valve directly to the flow generator 15, and from the flow generator 15 to the patient interface 12 (Figure 7).
Modified Westfall does not disclose obtaining, by the processor, a leak flow, calculating, by the processor, patient flow by subtracting the leak flow from the total flow generator flow output.
Zilberg discloses a leak flow (Note: this is considered to be leak around the patient interface such as a leak around a mask seal), calculating, by the processor, patient flow (Note: the examiner considers this to be inhalation and exhalation) by subtracting the leak flow (Note: this is considered to be leak around the patient interface such as a leak around a mask seal) from the total flow generator flow output (Note: this is considered the flow that leaves the flow generator). (Claim 4)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Westfall to be programmed to calculate a patient flow by subtracting the leak flow output from the total flow output as it would allow the device to determine when inspiration and expiration begins and determine the flow rates of air to the patient. (Zilberg: Page 2, Paragraph 4)
Modified Westfall does not disclose calculating, by the processor, patient tidal volume of gas inhaled by integrating the patient flow over a single breath.
Sackner discloses calculating, by the processor, patient tidal volume of gas inhaled by integrating the patient flow over a single breath. (Claim 3)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify Westfall to include calculating, by the processor, patient tidal volume of gas inhaled by integrating the patient flow over a single breath as the measurement of breath by breath peak inspiratory flow and acceleration, and breath by breath ventilation as the product of respiratory rate and tidal volume of the breath as herein described, also permit simultaneous computation of the ratio of respiratory drive to ventilation on either a breath by breath or a time average basis. (Page 15, Paragraph 2)
Regarding claim 19, Modified Westfall discloses the method as claimed in claim 18.
Modified Westfall discloses wherein the step of determining, by the processor, a total flow generator flow output based on the patient interface pressure and the oxygen input line flow (Claim 30), comprises the processor determining the total flow generator flow output based on at least one of: a pre-defined mathematical function stored in a memory accessible by the processor. (Paragraph 0033, 0080 & 0086)
Regarding claim 21, Modified Westfall discloses the method as claimed in claim 18.
Modified Westfall discloses wherein the method further comprises the step of calculating a concentration of oxygen in the patient flow to determine a fraction of inhaled oxygen. (Paragraph 0039)
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Westfall et al. (US 20200368482 A1) in view of Zilberg et al. (WO 2004/066804 A2) & Sackner et al. (WO 9841146 A1) as claimed in claim 18, in further view of Orr et al. (US 20160166797 A1).
Regarding claim 20, Modified Westfall discloses the method as claimed in claim 19.
Modified Westfall does not disclose wherein the step of obtaining, by the processor, a leak flow determining, by the processor, a pause period between a patient exhalation and a patient inhalation, and wherein the method further comprises the steps of: obtaining, by a processor, information relating to a patient interface pressure and an oxygen input line flow during the pause period, determining, by the processor, a flow generator leak flow based on the patient interface pressure and the oxygen input line flow during the pause period.
Orr discloses wherein the step of obtaining, by the processor, a leak flow (Note: the examiner considers the oxygen leak flow as the flow received in the pause between the inhalation and the exhalation) determining, by the processor, a pause period between a patient exhalation and a patient inhalation, and wherein the method further comprises the steps of: obtaining, by a processor, information relating to a patient interface pressure and an oxygen input line flow during the pause period, determining, by the processor, a flow generator leak flow based on the patient interface pressure and the oxygen input line flow during the pause period. (Paragraph 0097)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Westfall to include wherein the step of obtaining, by the processor, a leak flow determining, by the processor, a pause period between a patient exhalation and a patient inhalation, and wherein the method further comprises the steps of: obtaining, by a processor, information relating to a patient interface pressure and an oxygen input line flow during the pause period, determining, by the processor, a flow generator leak flow based on the patient interface pressure and the oxygen input line flow during the pause period as detecting the baseline pressure may be calculated by measuring the pressure at the time between a patient’s breaths i.e., the pause between inspiration and expiration (Paragraph 0097).
Claims 22 - 23 are rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (US 20160166797 A1) in view of Lynn et al. (US 2008/0200775 A1), Zilberg et al. (WO 2004/066804 A2), Emerson et al. (US 6546930 B1), ORR et al. (US 10786645 B2), Kennedy et al. (US 20220020488 A1) & Slessareb et al. (JP 2009502265 A)
Regarding claim 22, A method for calculating a percentage of oxygen in a volume of gas inhaled during an inhalation, the method comprising:
Orr discloses a processor 35,
However, it does not disclose a flow generator.
Lynn discloses a flow generator 115. (Paragraph 0019)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify Westfall to include a flow generator in order to deliver an airflow to the patient and in combination with the oxygen flow valve allow auto optimization of gas delivery for application during routine use. (Paragraph 0037)
Modified Orr discloses obtaining information relating to a flow generator input (Paragraph 0085 discloses the processor controls the oxygen flow meaning the processor contains the input information of the flow generator);
obtaining, by a processor 35, information relating to a flow generator output (Paragraph 0090 discloses the oxygen flow analyzer that gathers the output of the flow);
Modified Orr discloses the processor 35.
Modified Orr does not disclose determining an oxygen leak flow, calculating.
Zilberg discloses determining an oxygen leak flow by calculating. (Claim 4)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Westfall to be programmed to calculate a patient flow by subtracting the leak flow output from the total flow output as it would allow the device to determine when inspiration and expiration begins and determine the flow rates of air to the patient. (Page 2, Paragraph 4)
Orr does not disclose adding 21% of a difference between a total oxygen flow generator flow output (Note: this is considered to be the mix of the pure oxygen from the source and the entrained ambient air) and a total oxygen flow generator flow input over a time of the inhalation to the total oxygen flow generator flow input over the time of the inhalation.
However, ORR discloses the concentration of typical air is approximately 21%. Column 11, lines 1 – 10)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify Westfall to add 21% as it would allow the determination of how much supplemental oxygen is actually being provided to the patient that does rely on the oxygen concentration of typical air in a time period that is considered to be exhalation. (Column 11, lines 1 – 22)
Modified Orr does not disclose the difference between a total oxygen flow generator flow output and a total oxygen flow generator flow input over a time of the inhalation to the total oxygen flow generator flow input over the time of the inhalation
Kennedy discloses the difference between a total oxygen flow generator flow output and a total oxygen flow generator flow input over a time of the inhalation to the total oxygen flow generator flow input over the time of the inhalation. (Paragraph 0103)
It would be obvious to one of ordinary skill in the art prior to the effective filing date to further modify Westfall to include the difference between a total oxygen flow generator flow output and a total oxygen flow generator flow input over a time of the inhalation to the total oxygen flow generator flow input over the time of the inhalation as it would allow the calculation of the leak flow rate using several breathing cycles which include inhalation. (Paragraph 0103)
Modified Orr does not disclose a percentage of oxygen in a volume of gas inhaled by: subtracting the oxygen leak flow over the time of the inhalation to determine a volume of oxygen inhaled; and
dividing the volume of oxygen inhaled by a total volume of gas inhaled.
Emerson discloses subtracting the oxygen leak flow over the time of the inhalation to determine a volume of oxygen inhaled. (Column 5, lines 5 – 15)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify Westfall to include subtracting the oxygen leak flow over the time of the inhalation to determine a volume of oxygen inhaled as it would allow clear information of what the maximum flow is needed to be provided to the patient. (Column 5, lines 5 – 15)
Slessareb discloses dividing the volume of oxygen inhaled by a total volume of gas inhaled. (Page 10, Last paragraph)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify Westfall to include dividing the volume of oxygen inhaled by a total volume of gas inhaled as it would allow the knowledge of the concentration of oxygen inhaled by the patient. (Page 11, First paragraph)
Modified Orr does not disclose comprising oxygen from a source of compressed oxygen delivered through an oxygen input line.
However, modified Orr discloses it can receive information from the input of the oxygen flow. (Paragraph 0085 discloses the processor controls the oxygen flow meaning the processor contains the input information of the flow generator)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Westfall to include input information comprising oxygen from a source of compressed oxygen delivered through an oxygen input line as it would be based on the oxygen information that the processor is able to acquire. This is something that is already proved can be detected (Paragraph 0085)
Modified Orr does not expressly disclose output comprising oxygen from the source of compressed oxygen blended with ambient air entrained through air input ports of the flow generator
However, Modified Orr discloses it is able to obtain information of the flow generator output. (Paragraph 0090 discloses the oxygen flow analyzer that gathers the output of the flow);
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Westfall to include output information comprising oxygen from the source of compressed oxygen blended with ambient air entrained through air input ports of the flow generator as it would be based on the oxygen information that the processor is able to acquire. This is something that is already proved can be detected (Paragraph 0090)
Modified Orr discloses determining, by the processor, the total flow generator flow output based on a patient interface pressure and the flow generator input (Paragraph 0093 discloses the processor gathers information on the patients breathing pressure by the patient interface and is able to send the processor 35 the information), wherein the processor determines the total flow generator flow output (Paragraph 0099 & 0106 – 0107).
Modified Orr discloses detecting the total flow outputs without directly measuring the total flow generator flow output during inhalation. (Paragraph 0019 – 0023 discloses being able to do it during exhalation and not inhalation)
Modified Orr does not disclose using a polynomial function fitted to a plurality of pre-measured data points collected for a type of the flow generator at multiple combinations of patient interface pressures and oxygen input line flow rates.
However, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Westfall by using a polynomial function fitted to a plurality of pre-measured data points collected at multiple combinations of patient interface pressures and oxygen input line flow rates as polynomial functions are known in the art to take pre-measured data points form a plurality of combinations of information. This would be an obvious function to use based on the results wanted.
Regarding claim 23, discloses the method for calculating the percentage of oxygen in a volume of gas inhaled during an inhalation as claimed in claim 22.
Modified Orr wherein the step of determining, by the processor 35, the oxygen leak flow, comprises determining, by the processor 35, a pause period between a patient exhalation and a patient inhalation (Paragraph 0107), and wherein the method further comprises the steps of:
obtaining, by a processor 35, the flow generator output during the pause period between the patient exhalation and the patient inhalation (Paragraph 0107); and
determining, by the processor, a flow generator leak flow based on the flow generator output during the pause period (Paragraph 0050 discloses the action of subtracting the total amount of oxygen to be delivered, which is considered the total flow, to the calculated volume of oxygen delivered / Paragraph 0097 discloses determination of the flow found on the pause between the inhalation and the exhalation).
Conclusion
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/GRACIELA NATALIA LEBRON DE JESUS/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
