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 .
Status of the Claims
This Office Action is in responsive to the preliminary amendment filed on 9/20/2023. As directed by the Preliminary amendment, claims 1-288 were cancelled and claims 289-322 have been added. Thus, claims 289-322 are currently pending in this application.
Drawings
The drawings are objected to because Figs. 7-8, 11A-20A, 20C, and 20E-23 contain improper shading (see MPEP 608.02(V)(m)). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 289, 292, 306, 311-312, 315, and 321 are objected to because of the following informalities:
Claim 289 recites “a FIO2 setting” in line 10, and is suggested to read --a fraction of inspired oxygen (FIO2) setting-- in order to provide clarity for the acronym.
Claim 292 recites “the patient’s blood” in line 3, and is suggested to read --blood of the patient-- in order to ensure proper antecedent basis for the first claimed recitation of blood.
Claim 306 recites “any ambient air” in line 2, and is suggested to read --ambient air-- in order to ensure proper antecedent basis.
Claim 311 recites “wherein using, for the oxygen supplementation, the oxygen enriched gas comprises using, for the oxygen supplementation, oxygen enriched gas” in lines 2-4, and is suggested to read --wherein using, for the oxygen supplementation, oxygen enriched gas-- in order to avoid redundancy.
Claim 312 recites “the patient’s blood” in line 3, and is suggested to read --blood of the patient-- in order to ensure proper antecedent basis for the first claimed recitation of blood.
Claim 315 recites “the patient’s blood” in lines 5-6, and is suggested to read --blood of the patient-- in order to ensure proper antecedent basis for the first claimed recitation of blood.
Claim 315 recites “determining an oxygen concentrator system contribution, of oxygen enriched gas from an oxygen concentrator system, to the amount of oxygen supplementation, and determining a pressurized oxygen source contribution, of oxygen from at least one pressurized oxygen source, to the amount of oxygen supplementation, and” in lines 11-15, and is suggested to read --determining an oxygen concentrator system contribution of oxygen enriched gas from an oxygen concentrator system to the amount of oxygen supplementation, and determining a pressurized oxygen source contribution of oxygen from at least one pressurized oxygen source to the amount of oxygen supplementation, and-- in order be grammatically correct.
Claim 321 recites “the patient’s blood” in line 4, and is suggested to read --blood of the patient-- in order to ensure proper antecedent basis for the first claimed recitation of blood.
Appropriate correction is required.
Applicant is advised that should claim 316 be found allowable, claim 318 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 289-314 and 319-322 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.
Regarding claim 289, the limitation “gas to be delivered” in lines 9-10 is confusing, as it is unclear whether this limitation is meant to reference “gas delivery” in line 2, “oxygen enriched gas for delivery” in line 5, and/or “oxygen from the at least one pressurized oxygen source for delivery” in line 7, or if it is meant to be a new limitation.
Regarding claim 290, the phrase "preferentially" in line 2 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 295 recites the limitations "the minimum" in line 1 and “the maximum” in line 2. There is insufficient antecedent basis for these limitations in the claim.
Claim 302 recites the limitation “the density” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 303, the limitation “gas to be delivered” in line 9 is confusing, as it is unclear whether this limitation is meant to reference “gas delivery” in line 2, “oxygen enriched gas for delivery” in line 5, and/or “oxygen from the at least one pressurized oxygen source for delivery” in line 7, or if it is meant to be a new limitation. Moreover, the limitation “can be” in line 13 is confusing, as it is unclear whether the following limitations are required or not for the claimed invention.
Regarding claim 304, the phrase "preferentially" in line 2 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 306, the limitation “any oxygen” in lines 1-2 is confusing, as it is unclear whether this limitation is meant to include “oxygen enriched gas” and/or “oxygen from the at least one pressurized source” from claim 303, or if this is meant to be a new limitation.
Regarding claim 319, the limitation “gas to be delivered” in lines 6-7 is confusing, as it is unclear whether this limitation is meant to reference “gas delivery” in line 2 and/or “oxygen enriched gas for delivery” in line 5, or if it is meant to be a new limitation.
Any remaining claims are rejected based on their dependency on a rejected base claim.
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.
Claims 289-294, 296-297, 303-305, 307-308, 312-315, 317, and 319-321 are rejected under 35 U.S.C. 103 as being unpatentable over Tyomkin et al. (US 6,675,798 B1) in view of O’Reilly (US 2010/0331639 A1).
Regarding claim 289, as best understood, Tyomkin discloses an apparatus for providing mechanical ventilation to a patient (apparatus for providing oxygen flow to a patient) (abstract), comprising:
a gas delivery apparatus, configured for gas delivery to the patient (flow meter 310, two-way valve 311, servomotor 312, and regulating valve 313 receive the flow of gas to the patient) (Figs. 1, 3; col. 6 lines 40-47);
at least one oxygen concentrator, coupled with the gas delivery apparatus, for generating oxygen enriched gas for delivery to the patient via the gas delivery apparatus (primary oxygen supply 101/301 is an oxygen generator coupled flow meter 310, two-way valve 311, servomotor 312, and regulating valve 313 to produce an oxygen containing gas with less nitrogen, i.e. oxygen enriched gas, for the patient) (Figs. 1, 3; col. 6 lines 23-31);
at least one pressurized oxygen source, coupled with the gas delivery apparatus, for providing oxygen from the at least one pressurized oxygen source for delivery to the patient via the gas delivery apparatus (auxiliary oxygen supply system 303 with oxygen supply container 306 is coupled to flow meter 310, two-way valve 311, servomotor 312, and regulating valve 313 to supply auxiliary oxygen to the patient when needed) (Figs. 1, 3; col. 6 lines 32-39); and
a controller, in communication with the gas delivery apparatus, for causing gas to be delivered to the patient (control device 314 produces the regulating signal to adjust gas flow to the patient with regulating valve 313) (Figs. 1, 3; col. 6 lines 48-57), the controller being configured to:
determine an oxygen enriched gas flow rate of the oxygen enriched gas for the gas to be delivered to the patient and a pressurized oxygen source flow rate of the oxygen from the at least one pressurized oxygen source for the gas to be delivered to the patient (control device 314 has a detector device to determine if the primary supply 301 has a failure to supply or not, and to then permit the flow of oxygen from the auxiliary supply 303 if there is a failure or continue with the primary supply 301 if there is not a failure; control device 314 determines how the flow rate should be adjusted and then produces the regulating signal for regulating valve 313 to adjust gas flow to the patient, and valve 313 receive flows from either of the primary supply 301 or the auxiliary supply 303) (Figs. 1, 3; col. 6 lines 23-47), and
control the gas delivery apparatus to deliver the gas to the patient in accordance with the determined oxygen enriched gas flow rate and the determined pressurized oxygen source flow rate (control device 314 produces the regulating signal for regulating valve 313 to adjust gas flow to the patient, and valve 313 receive flows from either of the primary supply 301 or the auxiliary supply 303; if a failure was not determined, the determined adjusted flow would be from the primary supply 301 and the auxiliary supply 303 would not provide flow; if a failure was determined, the determined adjusted flow would be from the auxiliary supply 303 and the primary supply 301 would not provide flow) (Figs. 1, 3; col. 6 lines 23-47).
Tyomkin does not disclose having a patient interface, a controller for causing gas to be delivered to the patient in accordance with a FIO2 setting, the controller being configured to:
based at least in part on the FIO2 setting, determine an oxygen enriched gas flow rate of the oxygen enriched gas for the gas to be delivered to the patient and a pressurized oxygen source flow rate of the oxygen from the at least one pressurized oxygen source for the gas to be delivered to the patient, and control the gas delivery apparatus to deliver the gas to the patient in accordance with the FIO2 setting, the determined oxygen enriched gas flow rate, and the determined pressurized oxygen source flow rate.
However, Tyomkin does teach controlling the flow of oxygen to a patient based on the oxygen level in a patient’s bloodstream (Tyomkin; col. 4 lines 60-67; col. 5 lines 1-10). Moreover, O’Reilly teaches a system and method of indicating when adjustments should be made to the ventilation parameters of a medical ventilator (O’Reilly; para. [0010]) including having a patient interface (patient 102 can receive air from ventilator 150 via a face mask or intubation tube) (O’Reilly; para. [0012]) and a controller for causing gas to be delivered to the patient in accordance with a FIO2 setting (the FIO2 setting of delivered oxygen is manipulated to control the partial pressure of oxygen in the blood) (O’Reilly; para. [0029]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Tyomkin device to include a patient interface and to modify the Tyomkin controller to cause gas to be delivered to the patient in accordance with a FIO2 setting, as taught by O’Reilly, for the purpose of proving a specific suitable structure to interface the patient with a ventilator (O’Reilly; para. [0012]) and to provide a specific means to control the partial pressure of oxygen in the blood and the oxygen saturation of hemoglobin (O’Reilly; para. [0029]).
With this modification, the modified Tyomkin would thus teach a controller for causing gas to be delivered to the patient in accordance with a FIO2 setting, the controller being configured to: based at least in part on the FIO2 setting, determine an oxygen enriched gas flow rate of the oxygen enriched gas for the gas to be delivered to the patient and a pressurized oxygen source flow rate of the oxygen from the at least one pressurized oxygen source for the gas to be delivered to the patient, and control the gas delivery apparatus to deliver the gas to the patient in accordance with the FIO2 setting, the determined oxygen enriched gas flow rate, and the determined pressurized oxygen source flow rate (the Tyomkin control device 314 is modified by O’Reilly to use the FIO2 setting to control the partial pressure of oxygen in the blood, thereby using FIO2 in their determination of the adjustments to flow from the primary supply 301/auxiliary supply 303; the Tyomkin control device 314 has a detector device to determine if the primary supply 301 has a failure to supply or not, and to then permit the flow of oxygen from the auxiliary supply 303 if there is a failure or continue with the primary supply 301 if there is not a failure; Tyomkin control device 314 determines how the flow should be adjusted and then produces the regulating signal for regulating valve 313 to adjust gas flow to the patient, modified by O’Reilly to use the FIO2 setting in their flow adjustment determinations, and valve 313 receives flow from either of the primary supply 301 or the auxiliary supply 303) (Tyomkin, Figs. 1 and 3, col. 4 lines 60-67, col. 5 lines 1-10, col. 6 lines 23-47; O’Reilly, para. [0029]).
Regarding claim 290, as best understood, the modified Tyomkin teaches wherein the determination of the oxygen enriched gas flow rate and the pressurized oxygen source flow rate comprises preferentially using the oxygen enriched gas flow rate relative to the pressurized oxygen source flow rate (control device 314 flow is from the primary supply 301 unless it fails, and so prefers the primary supply 301 relative to the auxiliary supply 303) (Tyomkin; Figs. 1, 3; col. 6 lines 23-47).
Regarding claim 291, the modified Tyomkin teaches wherein the determination of the oxygen enriched gas flow rate and the pressurized oxygen source flow rate comprises using a maximum available oxygen enriched gas flow rate for the oxygen enriched gas flow rate, and supplementing the maximum available oxygen enriched gas flow rate using the pressurized oxygen source flow rate as necessary to achieve the FIO2 setting (when the Tyomkin primary supply 301 has a total cessation of flow failure such that the maximum available oxygen is 0, the control device 314 uses the flow from the auxiliary supply 303 as a supplement to reach the FIO2 setting needed for blood oxygen levels) (Tyomkin, Figs. 1 and 3, col. 4 lines 60-67, col. 5 lines 1-10 and 56-62, col. 6 lines 23-47; O’Reilly, para. [0029]).
Regarding claim 292, the modified Tyomkin teaches comprising: at least one oximetry sensor configured to generate signals representative of an oxygen concentration of the patient's blood, wherein the controller is configured to: based at least in part on the signals representative of the oxygen concentration of the patient's blood, determine the FIO2 setting for the gas to be delivered to the patient (Tyomkin oxygen-measuring sensor 315 generates a signal relative to the blood oxygen level to the control device 314 to regulate flow to achieve an O’Reilly FIO2 setting for a certain blood oxygen level) (Tyomkin, Figs. 1 and 3, col. 6 lines 48-57; O’Reilly, para. [0029]).
Regarding claim 293, the modified Tyomkin teaches wherein the controller is configured to: receive the signals representative of the oxygen concentration of the patient's blood from the at least one oximetry sensor during the delivery of the gas to the patient, based at least in part on the received signals, determine the oxygen concentration of the patient's blood, and based at least in part on the oxygen concentration of the patient's blood, determine the FIO2 setting (Tyomkin oxygen-measuring sensor 315 generates a signal relative to the blood oxygen level to the control device 314 to regulate flow to achieve an O’Reilly FIO2 setting for a certain blood oxygen level; in O’Reilly, the FIO2 setting of delivered oxygen is manipulated to control the partial pressure of oxygen in the blood) (Tyomkin, Figs. 1 and 3, col. 6 lines 48-57; O’Reilly, para. [0029]).
Regarding claim 294, the modified Tyomkin teaches wherein the controller is configured to adjust the FIO2 setting to maintain patient oxygenation at a desired level or range (Tyomkin oxygen-measuring sensor 315 generates a signal relative to the blood oxygen level to the control device 314 to regulate flow to achieve an O’Reilly FIO2 setting for a certain blood oxygen level; in O’Reilly, the FIO2 setting of delivered oxygen is manipulated to control the partial pressure of oxygen in the blood) (Tyomkin, Figs. 1 and 3, col. 6 lines 48-57; O’Reilly, para. [0029]), and wherein the controller is configured to utilize closed loop control based on oxygen concentration measurements of the patient's blood, comprising utilizing the at least one oximetry sensor to monitor the oxygen concentration of the patient's blood and adjusting oxygen delivery during the delivery of the gas to the patient to maintain the oxygen concentration of the patient's blood at the desired level or range (in O’Reilly, the FIO2 setting is increased to increase the current blood oxygen level, and the FIO2 setting is decreased to decrease the current blood oxygen level; as Tyomkin adjusts flow to reach a desired blood oxygen level, thus the modified Tyomkin would increase and decrease FIO2 as necessary as taught by O’Reilly in order to achieve the desired blood oxygen level as sensed by the sensor 315) (Tyomkin, Figs. 1 and 3, col. 6 lines 48-57; O’Reilly, para. [0029]).
Regarding claim 296, the modified Tyomkin teaches wherein, when the oxygen enriched gas flow rate is at a maximum available oxygen enriched gas flow rate (Tyomkin primary supply 301 can have a sufficient flow as its maximum available flow rate, or an insufficient/total cessation of flow failure such that the maximum available flow rate is insufficient or 0) (Tyomkin; col. 5 lines 56-62), the determination of the pressurized oxygen source flow rate is based at least in part on the FIO2 setting, an oxygen concentration of the oxygen enriched gas, an overall flow rate of the gas to be delivered to the patient, and the oxygen enriched gas flow rate (the Tyomkin control device 314 is modified by O’Reilly to use the FIO2 setting to control the partial pressure of oxygen in the blood, thereby using FIO2 in their determination of the adjustments to flow from the primary supply 301/auxiliary supply 303; thus, the modified Tyomkin determines the flow from the Tyomkin auxiliary supply 303 based on the O’Reilly FIO2 setting, an insufficient or 0 percentage of oxygen concentration from the failed Tyomkin primary supply 301, the total adjusted flow needed from the Tyomkin regulating valve 313 to be delivered to the patient, and the insufficient or 0 flow from the failed Tyomkin primary supply 301) (Tyomkin, Figs. 1 and 3, col. 4 lines 60-67, col. 5 lines 1-10 and 56-62, col. 6 lines 23-47; O’Reilly, para. [0029]).
Regarding claim 297, the modified Tyomkin teaches wherein the FIO2 setting is adjustable, and wherein the controller is configured to, based at least in part on adjustments to the FIO2 setting, make adjustments to the oxygen enriched gas flow rate and the pressurized oxygen source flow rate (the Tyomkin control device 314 uses the regulating valve 313 to adjust the flow rate to the patient, and the Tyomkin control device 314 modified by O’Reilly would use the FIO2 setting to control the partial pressure of oxygen in the blood, thereby using FIO2 in their determination of the adjustments to flow from the primary supply 301/auxiliary supply 303) (Tyomkin, Figs. 1 and 3, col. 4 lines 60-67, col. 5 lines 1-10 and 56-62, col. 6 lines 23-47; O’Reilly, para. [0029]).
Regarding claim 303, as best understood, Tyomkin discloses a system for providing mechanical ventilation to a patient (apparatus for providing oxygen flow to a patient) (abstract), comprising:
a gas delivery system, configured for gas delivery to the patient (flow meter 310, two-way valve 311, servomotor 312, and regulating valve 313 receive the flow of gas to the patient) (Figs. 1, 3; col. 6 lines 40-47);
at least one oxygen concentrator, coupled with the gas delivery system, for generating oxygen enriched gas for delivery to the patient via the gas delivery system (primary oxygen supply 101/301 is an oxygen generator coupled flow meter 310, two-way valve 311, servomotor 312, and regulating valve 313 to produce an oxygen containing gas with less nitrogen, i.e. oxygen enriched gas, for the patient) (Figs. 1, 3; col. 6 lines 23-31);
at least one pressurized oxygen source, coupled with the gas delivery system, for providing oxygen from the at least one pressurized oxygen source for delivery to the patient via the gas delivery system (auxiliary oxygen supply system 303 with oxygen supply container 306 is coupled to flow meter 310, two-way valve 311, servomotor 312, and regulating valve 313 to supply auxiliary oxygen to the patient when needed) (Figs. 1, 3; col. 6 lines 32-39); and
a controller for causing gas to be delivered to the patient (control device 314 produces the regulating signal to adjust gas flow to the patient with regulating valve 313) (Figs. 1, 3; col. 6 lines 48-57), the controller being configured to:
determine an amount of oxygen supplementation for the gas to be delivered to the patient (control device 314 determines the adjustments to flow to the patient needed from either of the primary supply 301 or the auxiliary supply 303) (Figs. 1, 3; col. 6 lines 23-47), comprising:
control the gas delivery system to deliver the gas to the patient in accordance the determined amount of oxygen supplementation (control device 314 produces the regulating signal for regulating valve 313 to achieve the determined gas flow adjustments for the patient, the valve 313 receiving flow from either of the primary supply 301 or the auxiliary supply 303) (Figs. 1, 3; col. 6 lines 23-47).
Tyomkin does not disclose having a patient interface, a controller for causing gas to be delivered to the patient in accordance with a FIO2 setting, the controller being configured to: based at least in part on the FIO2 setting, determine an amount of oxygen supplementation for the gas to be delivered to the patient, comprising: when the FIO2 setting can be achieved with use of only the oxygen enriched gas for the oxygen supplementation, using, for the oxygen supplementation, only the oxygen enriched gas, when the FIO2 setting cannot be achieved with use of only oxygen enriched gas for the oxygen supplementation, using, for the oxygen supplementation, the oxygen enriched gas and the oxygen from the at least one pressurized oxygen source, and control the gas delivery system to deliver the gas to the patient in accordance with the FIO2 setting and the determined amount of oxygen supplementation.
However, Tyomkin does teach controlling the flow of oxygen to a patient based on the oxygen level in a patient’s bloodstream (Tyomkin; col. 4 lines 60-67; col. 5 lines 1-10). Moreover, O’Reilly teaches a system and method of indicating when adjustments should be made to the ventilation parameters of a medical ventilator (O’Reilly; para. [0010]) including having a patient interface (patient 102 can receive air from ventilator 150 via a face mask or intubation tube) (O’Reilly; para. [0012]) and a controller for causing gas to be delivered to the patient in accordance with a FIO2 setting (the FIO2 setting of delivered oxygen is manipulated to control the partial pressure of oxygen in the blood) (O’Reilly; para. [0029]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Tyomkin device to include a patient interface and to modify the Tyomkin controller to cause gas to be delivered to the patient in accordance with a FIO2 setting, as taught by O’Reilly, for the purpose of proving a specific suitable structure to interface the patient with a ventilator (O’Reilly; para. [0012]) and to provide a specific means to control the partial pressure of oxygen in the blood and the oxygen saturation of hemoglobin (O’Reilly; para. [0029]).
With this modification, the modified Tyomkin would thus teach the controller being configured to: based at least in part on the FIO2 setting, determine an amount of oxygen supplementation for the gas to be delivered to the patient, comprising: when the FIO2 setting can be achieved with use of only the oxygen enriched gas for the oxygen supplementation, using, for the oxygen supplementation, only the oxygen enriched gas, when the FIO2 setting cannot be achieved with use of only oxygen enriched gas for the oxygen supplementation, using, for the oxygen supplementation, the oxygen enriched gas and the oxygen from the at least one pressurized oxygen source, and control the gas delivery system to deliver the gas to the patient in accordance with the FIO2 setting and the determined amount of oxygen supplementation (the Tyomkin control device 314 is modified by O’Reilly to use the FIO2 setting to control the partial pressure of oxygen in the blood, thereby using FIO2 in their determination of the adjustments to flow from the primary supply 301/auxiliary supply 303; the Tyomkin control device 314 has a detector device to determine if the primary supply 301 has a failure to supply or not, and to then permit the flow of oxygen from the auxiliary supply 303 only when there is a failure and to continue with the primary supply 301 if there is not a failure; Tyomkin control device 314 produces the regulating signal for regulating valve 313 to adjust gas flow to the patient, modified by O’Reilly to use the FIO2 setting in their flow adjustment determinations, and valve 313 receives flow from either of the primary supply 301 or the auxiliary supply 303) (Tyomkin, Figs. 1 and 3, col. 4 lines 60-67, col. 5 lines 1-10, col. 6 lines 23-47; O’Reilly, para. [0029]).
Regarding claim 304, as best understood, the modified Tyomkin teaches wherein the determination of the amount of oxygen supplementation comprises preferentially using the oxygen enriched gas for the oxygen supplementation relative to the oxygen from the at least one pressurized oxygen source (control device 314 flow is from the primary supply 301 unless it fails, and so it prefers the primary supply 301 relative to the auxiliary supply 303) (Tyomkin; Figs. 1, 3; col. 6 lines 23-47).
Regarding claim 305, the modified Tyomkin teaches wherein the determination of the amount of oxygen supplementation comprises using a maximum available amount of the oxygen enriched gas for the oxygen supplementation, and supplementing the maximum available amount of the oxygen enriched gas using the pressurized oxygen from the at least one pressurized oxygen source as necessary to achieve the FIO2 setting (when the Tyomkin primary supply 301 has a total cessation of flow failure such that the maximum available oxygen is 0, the control device 314 uses the flow from the auxiliary supply 303 as a supplement to reach the FIO2 setting needed for blood oxygen levels) (Tyomkin, Figs. 1 and 3, col. 4 lines 60-67, col. 5 lines 1-10 and 56-62, col. 6 lines 23-47; O’Reilly, para. [0029]).
Regarding claim 307, the modified Tyomkin teaches wherein the controller is configured to cause the gas to be delivered to the patient in accordance with the FIO2 setting, the determined amount of oxygen supplementation, and an overall flow rate for the gas to be delivered to the patient (the Tyomkin control device 314 is modified by O’Reilly to use the FIO2 setting to control the partial pressure of oxygen in the blood, thereby using FIO2 in their determination of the adjustments to flow from the primary supply 301/auxiliary supply 303; the modified Tyomkin control device 314 determines if flow from the primary supply 301/auxiliary supply 303 should be increased or decreased to reach an overall adjusted flow to be delivered to the patient to achieve a desired blood oxygenation level) (Tyomkin, Figs. 1 and 3, col. 4 lines 60-67, col. 5 lines 1-10, col. 6 lines 23-47; O’Reilly, para. [0027], para. [0029]).
Regarding claim 308, the modified Tyomkin teaches wherein the amount of oxygen supplementation comprises a flow rate of the oxygen enriched gas and a flow rate of the oxygen from the at least one pressurized oxygen source (control device 314 has a detector device to determine if the primary supply 301 has a failure to supply or not, and to then permit the flow of oxygen from the auxiliary supply 303 if there is a failure or continue with the primary supply 301 if there is not a failure; thus, if there is not a failure, the overall flow rate is the flow rate from the primary supply 301 and a flow rate of 0 from the auxiliary supply 303, and if there is a failure, the overall flow rate is the flow rate from the auxiliary supply 303 and a flow rate of 0 from the primary supply 301) (Tyomkin; Figs. 1, 3; col. 6 lines 23-47).
Regarding claim 312, the modified Tyomkin teaches comprising: at least one oximetry sensor configured to generate signals representative of an oxygen concentration of the patient's blood, wherein the controller is configured to: based at least in part on the signals representative of the oxygen concentration of the patient's blood, determine the FIO2 setting for the gas to be delivered to the patient (Tyomkin oxygen-measuring sensor 315 generates a signal relative to the blood oxygen level to the control device 314 to regulate flow to achieve an O’Reilly FIO2 setting for a certain blood oxygen level) (Tyomkin, Figs. 1 and 3, col. 6 lines 48-57; O’Reilly, para. [0029]).
Regarding claim 313, the modified Tyomkin teaches wherein the controller is configured to: receive the signals representative of the oxygen concentration of the patient's blood from the at least one oximetry sensor during the delivery of the gas to the patient, based at least in part on the received signals, determine the oxygen concentration of the patient's blood, and based at least in part on the oxygen concentration of the patient's blood, determine the FIO2 setting (Tyomkin oxygen-measuring sensor 315 generates a signal relative to the blood oxygen level to the control device 314 to regulate flow to achieve an O’Reilly FIO2 setting for a certain blood oxygen level; in O’Reilly, the FIO2 setting of delivered oxygen is manipulated to control the partial pressure of oxygen in the blood) (Tyomkin, Figs. 1 and 3, col. 6 lines 48-57; O’Reilly, para. [0029]).
Regarding claim 314, the modified Tyomkin teaches wherein the controller is configured to adjust the FIO2 setting to maintain patient oxygenation at a desired level or range (Tyomkin oxygen-measuring sensor 315 generates a signal relative to the blood oxygen level to the control device 314 to regulate flow to achieve an O’Reilly FIO2 setting for a certain blood oxygen level; in O’Reilly, the FIO2 setting of delivered oxygen is manipulated to control the partial pressure of oxygen in the blood) (Tyomkin, Figs. 1 and 3, col. 6 lines 48-57; O’Reilly, para. [0029]).
Regarding claim 315, Tyomkin discloses a method for controlling mechanical ventilation being provided to a patient (method of using an apparatus for providing oxygen flow to a patient) (abstract), comprising:
a controller controlling a gas delivery system, of a mechanical ventilation system, to deliver gas to the patient (control device 314 produces the regulating signal to adjust gas flow to the patient with regulating valve 313 of a system comprising a flow meter 310, two-way valve 311, servomotor 312, and regulating valve 313 to receive the flow of gas for the patient) (Figs. 1, 3; col. 6 lines 40-57).
Tyomkin does not disclose based at least in part on signals representative of an oxygen concentration of the patient's blood obtained from at least one oximetry sensor, determining a FIO2 setting for the gas to be delivered to the patient; and causing the gas to be delivered to the patient in accordance with the FIO2 setting, comprising: based at least in part on the FIO2 setting, determining an amount of oxygen supplementation for the gas to be delivered to the patient, comprising determining an oxygen concentrator system contribution, of oxygen enriched gas from an oxygen concentrator system, to the amount of oxygen supplementation, and determining a pressurized oxygen source contribution, of oxygen from at least one pressurized oxygen source, to the amount of oxygen supplementation, and controlling the gas delivery system to deliver the gas to the patient in accordance with the FIO2 setting and the determined amount of oxygen supplementation.
However, Tyomkin does teach controlling the flow of oxygen to a patient based on the oxygen level in a patient’s bloodstream (Tyomkin; col. 4 lines 60-67; col. 5 lines 1-10). Moreover, O’Reilly teaches a system and method of indicating when adjustments should be made to the ventilation parameters of a medical ventilator (O’Reilly; para. [0010]) including based at least in part on signals representative of an oxygen concentration of the patient's blood obtained from at least one oximetry sensor (noninvasive sensor 110 used to produce a signal to determine a patient’s blood oxygen saturation) (O’Reilly; paras. [0013-0014]), determining a FIO2 setting for the gas to be delivered to the patient (the patient’s partial pressure of oxygen in the blood is monitored so the FIO2 can be adjusted accordingly) (O’Reilly; para. [0027]); and causing the gas to be delivered to the patient in accordance with the FIO2 setting, comprising: based at least in part on the FIO2 setting, determining an amount of oxygen supplementation for the gas to be delivered to the patient (the FIO2 setting of oxygen delivered to the patient is increased or decreased to control the partial pressure of oxygen in the blood) (O’Reilly; para. [0027]; para. [0029]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Tyomkin method to include at least in part on signals representative of an oxygen concentration of the patient's blood obtained from at least one oximetry sensor, determining a FIO2 setting for the gas to be delivered to the patient; and causing the gas to be delivered to the patient in accordance with the FIO2 setting, comprising: based at least in part on the FIO2 setting, determining an amount of oxygen supplementation for the gas to be delivered to the patient, as taught by O’Reilly, for the purpose of providing a specific means to control the partial pressure of oxygen in the blood and the oxygen saturation of hemoglobin (O’Reilly; para. [0029]).
With this modification, the modified Tyomkin would thus teach comprising determining an oxygen concentrator system contribution, of oxygen enriched gas from an oxygen concentrator system, to the amount of oxygen supplementation, and determining a pressurized oxygen source contribution, of oxygen from at least one pressurized oxygen source, to the amount of oxygen supplementation, and controlling the gas delivery system to deliver the gas to the patient in accordance with the FIO2 setting and the determined amount of oxygen supplementation (the Tyomkin control device 314 is modified by O’Reilly to use the FIO2 setting to control the partial pressure of oxygen in the blood, thereby using FIO2 in their determination of the adjustments to flow from the primary supply 301/auxiliary supply 303; the Tyomkin control device 314 has a detector device to determine if the primary supply 301 has a failure to supply or not, and to then permit the flow of oxygen from the auxiliary supply 303 if there is a failure or continue with the primary supply 301 if there is not a failure; Tyomkin control device 314 produces the regulating signal for regulating valve 313 to adjust gas flow to the patient, modified by O’Reilly to use the FIO2 setting in their flow adjustment determinations, and valve 313 receives flow from either of the primary supply 301 or the auxiliary supply 303) (Tyomkin, Figs. 1 and 3, col. 4 lines 60-67, col. 5 lines 1-10, col. 6 lines 23-47; O’Reilly, para. [0029]).
Regarding claim 317, the modified Tyomkin teaches comprising the controller utilizing closed loop control based on oxygen concentration measurements of the patient's blood, comprising utilizing the at least one oximetry sensor to monitor the oxygen concentration of the patient's blood and adjusting oxygen delivery during the delivery of the gas to the patient to maintain the oxygen concentration of the patient's blood at a desired level or range (in O’Reilly, the FIO2 setting is increased to increase the current blood oxygen level, and the FIO2 setting is decreased to decrease the current blood oxygen level; as Tyomkin adjusts flow to reach a desired blood oxygen level, thus the modified Tyomkin would increase and decrease FIO2 as necessary as taught by O’Reilly in order to achieve the desired blood oxygen level as sensed by the sensor 315) (Tyomkin, Figs. 1 and 3, col. 6 lines 48-57; O’Reilly, para. [0029]).
Regarding claim 319, as best understood, Tyomkin discloses an apparatus for providing mechanical ventilation to a patient (apparatus for providing oxygen flow to a patient) (abstract), comprising:
a gas delivery apparatus, configured for gas delivery to the patient (flow meter 310, two-way valve 311, servomotor 312, and regulating valve 313 receive the flow of gas to the patient) (Figs. 1, 3; col. 6 lines 40-47);
at least one oxygen concentrator, coupled with the gas delivery apparatus, for generating oxygen enriched gas for delivery to the patient via the gas delivery apparatus (primary oxygen supply 101/301 is an oxygen generator coupled flow meter 310, two-way valve 311, servomotor 312, and regulating valve 313 to produce an oxygen containing gas with less nitrogen, i.e. oxygen enriched gas, for the patient) (Figs. 1, 3; col. 6 lines 23-31); and
a controller, in communication with the gas delivery apparatus, for causing gas to be delivered to the patient (control device 314 produces the regulating signal to adjust gas flow to the patient with regulating valve 313) (Figs. 1, 3; col. 6 lines 48-57), the controller being configured to:
determine an oxygen enriched gas flow rate of the oxygen enriched gas for the gas to be delivered to the patient (control device 314 determines the adjustments to flow needed from the functioning the primary supply 301) (Figs. 1, 3; col. 6 lines 23-47), and
control the gas delivery apparatus to deliver the gas to the patient in accordance with the determined oxygen enriched gas flow rate (control device 314 produces the regulating signal for regulating valve 313 to achieve the determined gas flow adjustments for the patient, the valve 313 receiving flow from the functioning primary supply 301) (Figs. 1, 3; col. 6 lines 23-47).
Tyomkin does not disclose having a patient interface, a controller for causing gas to be delivered to the patient in accordance with a FIO2 setting, the controller being configured to: based at least in part on the FIO2 setting, determine an oxygen enriched gas flow rate of the oxygen enriched gas for the gas to be delivered to the patient, and control the gas delivery apparatus to deliver the gas to the patient in accordance with the FIO2 setting and the determined oxygen enriched gas flow rate.
However, Tyomkin does teach controlling the flow of oxygen to a patient based on the oxygen level in a patient’s bloodstream (Tyomkin; col. 4 lines 60-67; col. 5 lines 1-10). Moreover, O’Reilly teaches a system and method of indicating when adjustments should be made to the ventilation parameters of a medical ventilator (O’Reilly; para. [0010]) including having a patient interface (patient 102 can receive air from ventilator 150 via a face mask or intubation tube) (O’Reilly; para. [0012]) and a controller for causing gas to be delivered to the patient in accordance with a FIO2 setting (the FIO2 setting of delivered oxygen is manipulated to control the partial pressure of oxygen in the blood) (O’Reilly; para. [0029]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Tyomkin device to include a patient interface and to modify the Tyomkin controller to cause gas to be delivered to the patient in accordance with a FIO2 setting, as taught by O’Reilly, for the purpose of proving a specific suitable structure to interface the patient with a ventilator (O’Reilly; para. [0012]) and to provide a specific means to control the partial pressure of oxygen in the blood and the oxygen saturation of hemoglobin (O’Reilly; para. [0029]).
With this modification, the modified Tyomkin would thus teach a controller for causing gas to be delivered to the patient in accordance with a FIO2 setting, the controller being configured to: based at least in part on the FIO2 setting, determine an oxygen enriched gas flow rate of the oxygen enriched gas for the gas to be delivered to the patient, and control the gas delivery apparatus to deliver the gas to the patient in accordance with the FIO2 setting and the determined oxygen enriched gas flow rate (the Tyomkin control device 314 is modified by O’Reilly to use the FIO2 setting to control the partial pressure of oxygen in the blood, thereby using FIO2 in their determination of the adjustments to flow from the functioning primary supply 301; Tyomkin control device 314 produces the regulating signal for regulating valve 313 to adjust gas flow to the patient, modified by O’Reilly to use the FIO2 setting in their flow adjustment determinations, and valve 313 receives flow from the functioning primary supply 301) (Tyomkin, Figs. 1 and 3, col. 4 lines 60-67, col. 5 lines 1-10, col. 6 lines 23-47; O’Reilly, para. [0029]).
Regarding claim 320, the modified Tyomkin teaches comprising at least one pressurized oxygen source, coupled with the gas delivery apparatus, for providing oxygen from the at least one pressurized oxygen source for delivery to the patient via the gas delivery apparatus (auxiliary oxygen supply system 303 with oxygen supply container 306 is coupled to flow meter 310, two-way valve 311, servomotor 312, and regulating valve 313 to supply auxiliary oxygen to the patient when needed) (Tyomkin; Figs. 1, 3; col. 6 lines 32-39), and wherein the controller is configured to: based at least in part on the FIO2 setting, determine the oxygen enriched gas flow rate of the oxygen enriched gas for the gas to be delivered to the patient and a pressurized oxygen source flow rate of the oxygen from the at least one pressurized oxygen source for the gas to be delivered to the patient, and control the gas delivery apparatus to deliver the gas to the patient in accordance with the FIO2 setting, the determined oxygen enriched gas flow rate, and the determined pressurized oxygen source flow rate (the Tyomkin control device 314 is modified by O’Reilly to use the FIO2 setting to control the partial pressure of oxygen in the blood, thereby using FIO2 in their determination of the adjustments to flow from the primary supply 301/auxiliary supply 303; the Tyomkin control device 314 has a detector device to determine if the primary supply 301 has a failure to supply or not, and to then permit the flow of oxygen from the auxiliary supply 303 if there is a failure or continue with the primary supply 301 if there is not a failure; Tyomkin control device 314 produces the regulating signal for regulating valve 313 to adjust gas flow to the patient, modified by O’Reilly to use the FIO2 setting in their flow adjustment determinations, and valve 313 receives flow from either of the primary supply 301 or the auxiliary supply 303) (Tyomkin, Figs. 1 and 3, col. 4 lines 60-67, col. 5 lines 1-10, col. 6 lines 23-47; O’Reilly, para. [0029]).
Regarding claim 321, the modified Tyomkin teaches wherein the controller is configured to adjust the FIO2 setting to maintain patient oxygenation at a desired level or range (Tyomkin oxygen-measuring sensor 315 generates a signal relative to the blood oxygen level to the control device 314 to regulate flow to achieve an O’Reilly FIO2 setting for a certain blood oxygen level; in O’Reilly, the FIO2 setting of delivered oxygen is manipulated to control the partial pressure of oxygen in the blood) (Tyomkin, Figs. 1 and 3, col. 6 lines 48-57; O’Reilly, para. [0029]), and wherein the controller is configured to utilize closed loop control based on oxygen concentration measurements of the patient's blood, comprising utilizing at least one oximetry sensor to monitor the oxygen concentration of the patient's blood and adjusting oxygen delivery during the delivery of the gas to the patient to maintain the oxygen concentration of the patient's blood at the desired level or range (in O’Reilly, the FIO2 setting is increased to increase the current blood oxygen level, and the FIO2 setting is decreased to decrease the current blood oxygen level; as Tyomkin adjusts flow to reach a desired blood oxygen level, thus the modified Tyomkin would increase and decrease FIO2 as necessary as taught by O’Reilly in order to achieve the desired blood oxygen level as sensed by the sensor 315) (Tyomkin, Figs. 1 and 3, col. 6 lines 48-57; O’Reilly, para. [0029]).
Claims 295 and 298-299 are rejected under 35 U.S.C. 103 as being unpatentable over Tyomkin in view of O’Reilly as applied to claims 289 and 294 above, and further in view of Uchiyama et al. (US 2009/0255403 A1).
Regarding claim 295, as best understood, the modified Tyomkin teaches the invention as previously claimed, but does not teach wherein the minimum available oxygen enriched gas flow rate is between 0.1 and 1.0 L/min and the maximum available oxygen enriched gas flow rate is between 2.5 and 3.5 L/min.
However, Uchiyama teaches an oxygen concentrator (Uchiyama; abstract) including wherein the minimum available oxygen enriched gas flow rate is between 0.1 and 1.0 L/min and the maximum available oxygen enriched gas flow rate is between 2.5 and 3.5 L/min (a two cylinder-type oxygen concentrator is capable of predetermined oxygen flow rates of 0.25 L/min and 3 L/min) (Uchiyama; para. [0066]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Tyomkin device such that the minimum available oxygen enriched gas flow rate is between 0.1 and 1.0 L/min and the maximum available oxygen enriched gas flow rate is between 2.5 and 3.5 L/min, as taught by Uchiyama, for the purpose of providing an oxygen-concentrated gas of 88%-93% oxygen to a user (Uchiyama; para. [0066]).
Regarding claim 298, the modified Tyomkin teaches wherein the oxygen enriched gas has an oxygen concentration of between 90% and 96% (two cylinder-type oxygen concentrator can provide an oxygen-concentrated gas of 93% oxygen) (Uchiyama; para. [0066]).
Regarding claim 299, the modified Tyomkin teaches wherein the oxygen enriched gas has an oxygen concentration of 93% (two cylinder-type oxygen concentrator can provide an oxygen-concentrated gas of 93% oxygen) (Uchiyama; para. [0066]).
Claims 300-301, 310-311, 316, 318, and 322 are rejected under 35 U.S.C. 103 as being unpatentable over Tyomkin in view of O’Reilly as applied to claims 289, 303, 315, and 319 above, and further in view of Friedman et al. (US 8,702,840 B1).
Regarding claim 300, the modified Tyomkin teaches the invention as previously claimed, but does not teach wherein the at least one oxygen concentrator comprises at least two oxygen concentrators.
However, Friedman teaches an apparatus for managing an oxygen generating system (Friedman; abstract) wherein the at least one oxygen concentrator comprises at least two oxygen concentrators (system can have a plurality of oxygen generators 141-146) (Friedman; Figs. 1A-10; col. 9 lines 14-35; col. 10 lines 61-63).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Tyomkin at least one oxygen concentrator to include at least two oxygen concentrators, as taught by Friedman, for the purpose of allowing individual oxygen generators/concentrators to be removed, exchanged, repaired, or replaced without causing the rest of the oxygen generator system to fail (Friedman; col. 9 lines 14-35).
Regarding claim 301, the modified Tyomkin teaches wherein the at least two oxygen concentrators comprises a first oxygen concentrator and a second oxygen concentrator (oxygen generators 141, 142) (Friedman; Figs. 1A-10; col. 9 lines 14-35; col. 10 lines 61-63), and wherein determining the gas flow rate of the oxygen enriched gas comprises determining a first gas flow rate for oxygen enriched gas from the first oxygen concentrator and a second gas flow rate for oxygen enriched gas from the second oxygen concentrator (the digital controller 403 can variably control the speed or output of individual oxygen generators, wherein output can be oxygen compressor output flow; thus, the individual output flows of oxygen generators 141, 142 can be individually determined and controlled to achieve an overall output flow) (Friedman; Figs. 1A-10; col. 7 lines 23-28; col. 15 lines 38-46).
Regarding claim 310, the modified Tyomkin teaches wherein the at least one oxygen concentrator comprises at least two oxygen concentrators (system can have a plurality of oxygen generators 141-146) (Friedman; Figs. 1A-10; col. 9 lines 14-35; col. 10 lines 61-63).
Regarding claim 311, the modified Tyomkin teaches wherein the at least two oxygen concentrators comprise a first oxygen concentrator and second oxygen concentrator (oxygen generators 141, 142) (Friedman; Figs. 1A-10; col. 9 lines 14-35; col. 10 lines 61-63), and wherein using, for the oxygen supplementation, the oxygen enriched gas comprises using, for the oxygen supplementation, oxygen enriched gas from the first oxygen concentrator and oxygen enriched gas from the second oxygen concentrator (the digital controller 403 can variably control the speed or output of individual oxygen generators, wherein output can be oxygen compressor output flow; thus, the individual output flows of oxygen generators 141, 142 can be individually determined and controlled to achieve an overall output flow) (Friedman; Figs. 1A-10; col. 7 lines 23-28; col. 15 lines 38-46).
Regarding claim 316, the modified Tyomkin teaches wherein the oxygen concentrator system comprises at least two oxygen concentrators, comprising a first oxygen concentrator and a second oxygen concentrator (oxygen generators 141, 142) (Friedman; Figs. 1A-10; col. 9 lines 14-35; col. 10 lines 61-63), and wherein determining the oxygen concentrator system contribution comprises determining a first oxygen concentrator contribution from the first oxygen concentrator and a second oxygen concentrator contribution from the second oxygen concentrator (the digital controller 403 can variably control the speed or output of individual oxygen generators, wherein output can be oxygen compressor output flow; thus, the individual output flows of oxygen generators 141, 142 can be individually determined and controlled to achieve an overall output flow) (Friedman; Figs. 1A-10; col. 7 lines 23-28; col. 15 lines 38-46).
Regarding claim 318, the modified Tyomkin teaches wherein the oxygen concentrator system comprises at least two oxygen concentrators comprising a first oxygen concentrator and a second concentrator (oxygen generators 141, 142) (Friedman; Figs. 1A-10; col. 9 lines 14-35; col. 10 lines 61-63), and wherein determining the oxygen concentrator system contribution comprises determining a contribution from the first oxygen concentrator and a contribution from the second oxygen concentrator (the digital controller 403 can variably control the speed or output of individual oxygen generators, wherein output can be oxygen compressor output flow; thus, the individual output flows of oxygen generators 141, 142 can be individually determined and controlled to achieve an overall output flow) (Friedman; Figs. 1A-10; col. 7 lines 23-28; col. 15 lines 38-46).
Regarding claim 322, the modified Tyomkin teaches wherein the at least one oxygen concentrator comprises at least two oxygen concentrators comprising a first oxygen concentrator and a second oxygen concentrator (oxygen generators 141, 142) (Friedman; Figs. 1A-10; col. 9 lines 14-35; col. 10 lines 61-63), and wherein determining the gas flow rate of the oxygen enriched gas comprises determining a first gas flow rate for oxygen enriched gas from the first oxygen concentrator and a second gas flow rate for oxygen enriched gas from the second oxygen concentrator (the digital controller 403 can variably control the speed or output of individual oxygen generators, wherein output can be oxygen compressor output flow; thus, the individual output flows of oxygen generators 141, 142 can be individually determined and controlled to achieve an overall output flow) (Friedman; Figs. 1A-10; col. 7 lines 23-28; col. 15 lines 38-46).
Claim 302 is rejected under 35 U.S.C. 103 as being unpatentable over Tyomkin in view of O’Reilly as applied to claim 289 above, and further in view of James (US 2021/0299391 A1).
Regarding claim 302, as best understood, the modified Tyomkin teaches the invention as previously claimed, but does not teach wherein determining the oxygen enriched gas flow rate comprises calculating and taking into account a difference between the density of the oxygen enriched gas and a density of air.
However, James teaches a device with an integrated oxygen concentrator (James; abstract) including wherein determining the oxygen enriched gas flow rate comprises calculating and taking into account a difference between the density of the oxygen enriched gas and a density of air (oxygen concentrator compresses the surrounding air to the required density and then delivers the concentrated oxygen in a stream to the patient, and thus the oxygen concentrator must calculate and take into account the difference between the density of the surrounding air and the required density of the concentrated oxygen in order to know how to reach the required density from using the surrounding air) (James; para. [0038]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Tyomkin controller such that determining the oxygen enriched gas flow rate comprises calculating and taking into account a difference between the density of the oxygen enriched gas and a density of air, as taught by James, for the purpose of ensuring a required density of oxygen concentration can be delivered to the patient to thereby help treat a breathing condition (James; para. [0003]; para. [0038]).
Claims 306 and 309 are rejected under 35 U.S.C. 103 as being unpatentable over Tyomkin in view of O’Reilly as applied to claims 303 and 308 above, and further in view of Ahmad (US 2012/0006326 A1).
Regarding claim 306, as best understood, the modified Tyomkin teaches the invention as previously claimed, but does not teach wherein the oxygen supplementation supplements any oxygen provided by any ambient air included in the gas being delivered to the patient.
However, Ahmad teaches a ventilator (Ahmad; abstract) wherein the oxygen supplementation supplements any oxygen provided by any ambient air included in the gas being delivered to the patient (air pathway 120 supplies ambient air and oxygen pathway 140 supplies the more concentrated oxygen, and they mix to achieve a desired percentage or concentration of oxygen for the mixed gas) (Ahmad; Fig. 1; paras. [0013-0014]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Tyomkin oxygen supplementation such that the oxygen supplementation supplements any oxygen provided by any ambient air included in the gas being delivered to the patient, as taught by Ahmad, for the purpose of providing a means for controlling the percentage of oxygen in the mixed gas to the patient (Ahmad; paras. [0013-0014]).
Regarding claim 309, the modified Tyomkin teaches wherein the overall flow rate comprises a flow rate of ambient air (air pathway 120 supplies ambient air at a flow rate and oxygen pathway 140 supplies the more concentrated oxygen at a flow rate, and they mix to yield a flow rate of mixed air to a patient) (Ahmad; Fig. 1; paras. [0013-0014]; para. [0016]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2016/0279377 A1 by DeVries et al. is considered to be relevant as it discloses a ventilator with two gas pathways that produce a mixed gas with a certain concentration of oxygen.
US 2020/0368482 A1 by Westfall et al. is considered to be relevant as it discloses an oxygen concentrator with one flow path for an oxygen compressor and another for ambient air to bypass the compressor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE M PINDERSKI whose telephone number is (571)272-7032. The examiner can normally be reached Monday-Friday 7:00-4:00.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785