DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
Claim 3 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Species B, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on September 30, 2025.
Applicant's election with traverse of species restrictions in the reply filed on September 30, 2025 is acknowledged. The traversal is on the ground(s) that there is not search burden and also that the species should not be separated. This is not found persuasive because searching for nasal, oral, and nasal and oral mask together is search burden because: examination burden comes from developing and analyzing synonyms from each different class and examination burden would also increase exponentially in subsequent actions as the subject matter further diverges due to increasing specificity of the separately classed claimed elements. Also, as for the different species, there is Species A that is directed to is just nasal mask (E.g. Figs. 20A-20F), Species B is directed to a mask only as in there is no nasal prongs and just a full mask (Fig. 24, 25A-25B), Lastly, Species C is directed to a full mask and also has nasal prongs (Fig. 10A, 12-13). The independent claim teaches all three species as it just teaches “patient interface”.
Therefore, the requirement is still deemed proper and is therefore made FINAL.
Response to Amendment
This office action is responsive to the amendment filed on February 26, 2026 As directed by the amendment: claims 2, 12, 17-20, 23, 25-28 have been amended, no claims have been canceled, and no claims have been added. Thus, claims 1-28 are presently pending in the application.
Response to Arguments
Applicant argues on page 10 of the remarks that the objection made on the claims should be withdrawn. Previously, examiner suggests a few claim objections. Applicant response is persuasive, the previous claim objections has been hereby withdrawn.
Applicant argues on page 10-11 of the of the remarks that prior art of Clausson is not prior art. Applicant argument is persuasive and a second Non-Final is issued below.
Applicant argues on page 11-12 of the remarks that the 103-rejection is improper. Applicant argument are considered however are not found persuasive as Aylsworth teaches that they could be controlled individually could be interpreted as being capable of being done simultaneously as it is configured for language making the limitation functional. Also, in response to Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection is given.
Double patenting rejection still stands on the merit.
Claim Interpretation
Regarding the limitation in claims 11 and 23, “determine the predetermined pressure and the predetermined flow rate to restrict the predetermined pressure and the predetermined flow rate to a curve of equal efficacy”, the examiner is interpretating that the pressure and flow parameters are “restricted”/plotted on the curve of the graph on how efficient the generator is working.
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 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-5, 7-8, 16-20, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Barnes (WO 2006102708 A1) in view of Aylsworth et al. (US 20050011523 A1), hereafter as Aylsworth.
Regarding Claim 1, Barnes discloses a system (Fig. 1; 10) for delivery of a flow of air to a patient's airways (para. 0022-0031) comprising: a flow generator (Fig. 1; 20; para. 0023) configured to provide air to a patient (This limitation is functional) via an air circuit (Fig. 1; 40; para. 0022) and a patient interface(Fig. 1; 30); an adjustable vent (Fig. 1; 50; para. 0028); and one or more controllers (Fig. 1; 26, 52; para. 0023, 0028) configured to (This limitation is functional):
determine a pressure (para. 0023) and a flow rate (para. 0028) of the air being provided to the patient via the patient interface with a plurality of sensors (claim 16, measuring device 24, and pressure transducers; para. 0023); and control the flow generator and the adjustable vent (Fig. 1-2; para. 0023-0032).
Barnes does not specifically disclose that the system simultaneously control the pressure and the flow rate of the air at the patient interface to correspond with a predetermined pressure and a predetermined flow rate, respectively.
However, Aylsworth teaches that the system simultaneously control the pressure and the flow rate of the air at the patient interface to correspond with a predetermined pressure and a predetermined flow rate, respectively (para. 0053; Examiner notes: the gas flow and/or pressure to the nostrils and mouth may be individually controlled which is interpreted as being capable of being done “simultaneously” because mouth the nose and mouth have separately controllable blowers and associated sensors as seen in Fig. 2).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the sensing system in Barnes to include that the system simultaneously control the pressure and the flow rate of the air at the patient interface to correspond with a predetermined pressure and a predetermined flow rate, respectively as taught by Aylsworth for the purpose of the gas flow and/or pressure to the nostrils and mouth may be individually controlled which is interpreted as being capable of being done “simultaneously” because mouth the nose and mouth have separately controllable blowers and associated sensors (para. 0053).
Regarding Claim 2, Modified Barnes discloses the system of claim 1, further comprising the patient interface (Fig. 1; 30), wherein the patient interface comprises a projection portion configured to conduct a flow of the air into a naris of a patient and a mask portion configured to apply pressure of the air to the patient (para. 0025; Examiner notes: the patient interface 30 can be a full mask, nasal mask, nasal prongs, … etc.).
Regarding Claim 4, Modified Barnes discloses the system of claim 2, wherein the plurality of sensors comprise:
Modified Barnes does not specifically teach a pressure sensor for determining a measured pressure of the air; and a flow rate sensor for determining a measured flow rate of the air through the projection portion of the patient interface.
However, Aylsworth teaches a pressure sensor for determining a measured pressure of the air; and a flow rate sensor for determining a measured flow rate of the air through the projection portion of the patient interface (Fig. 3, flow sensors 34, 42, 43 and pressure transducers 36, 44, 45; para. 0039).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the sensing system in Modified Barnes to include the pressure sensor for determining a measured pressure of the air; and a flow rate sensor for determining a measured flow rate of the air through the projection portion of the patient interface as taught by Aylsworth for the purpose of the gas flow and/or pressure to the nostrils and mouth may be individually controlled which is interpreted as being capable of being done “simultaneously” because mouth the nose and mouth have separately controllable blowers and associated sensors (para. 0053).
Regarding Claim 5, Modified Barnes discloses the system of claim 4, wherein at least one of the pressure sensor and the flow rate sensor is located at an output of the flow generator (Fig. 3; Aylsworth).
Regarding Claim 7, Modified Barnes discloses the system of claim 1,
Modified Barnes does not specifically disclose wherein the one or more controllers are further configured to maintain at least one of the predetermined pressure and the predetermined flow rate at a constant value for a period of time.
However, Aylsworth teaches wherein the one or more controllers are further configured to maintain at least one of the predetermined pressure and the predetermined flow rate at a constant value for a period of time (Examiner notes: this limitation is functional; para. 0051-0053; the flow rate to the nares may be constantly kept at zero until a predetermined period of time passes which would be the time it takes to detect an obstruction and the pressure applied to the mouth is constant at zero until a predetermined period of time passes which would be the time it takes to detect an obstructing congested nostril which triggers a pressure change to the mouth).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the controllers in Modified Barnes to maintain at least one of the predetermined pressure and the predetermined flow rate at a constant value for a period of time as taught by Aylsworth for the purpose of detecting an obstructing congested nostril (0053).
Regarding Claim 8, Modified Barnes discloses the system of claim 1,
Modified Barnes does not specifically disclose wherein the one or more controllers are further configured to vary the predetermined pressure in accordance with a breathing cycle of the patient.
However, Aylsworth teaches wherein at least one or more controllers are further configured to vary the predetermined pressure in accordance with a breathing cycle of the patient (Examiner notes: this limitation is functional, para. 0055; reducing the pressure supplied to the patient during exhalation. The prescribed pressure thus varies over time which corresponds to the breathing cycle – exhalation vs. inhalation).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the controllers in Modified Barnes to vary the predetermined pressure in accordance with a breathing cycle of the patient as taught by Aylsworth for the purpose of reducing the pressure within the patient's airways to ease the patient effort required to exhale and making sure the patient is comfortable (0055).
Regarding Claim 16, Barnes discloses a method for controlling a supply of air to a patient's airways (para. 0022-0031) for a respiratory therapy (para. 0022-0031), the method comprising:
identifying, by one or more controllers(Fig. 1; 26, 52; para. 0023, 0028), a predetermined pressure and a predetermined flow rate of the air to be provided to a patient via an air circuit (Fig. 1; 40; para. 0022) and a patient interface (Fig. 1-2; 30; para. 0023-0032).;
determining, with a plurality of sensors (claim 16, measuring device 24, and pressure transducers; para. 0023), a pressure (para. 0023) and a flow rate (para. 0028) of the air being provided to the patient via the patient interface;
and controlling, by the one or more controllers, a flow generator (Fig. 1; 20; para. 0023) configured to provide the air to the patient interface (This limitation is functional), and an adjustable vent (Fig. 1; 50; para. 0028);
Barnes does not specifically disclose that the system as to simultaneously control the pressure and the flow rate of the air at the patient interface to correspond with the predetermined pressure and the predetermined flow rate, respectively.
However, Aylsworth teaches that the system simultaneously control the pressure and the flow rate of the air at the patient interface to correspond with a predetermined pressure and a predetermined flow rate, respectively (para. 0053; Examiner notes: the gas flow and/or pressure to the nostrils and mouth may be individually controlled which is interpreted as being capable of being done “simultaneously” because mouth the nose and mouth have separately controllable blowers and associated sensors as seen in Fig. 2).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the sensing system in Barnes to include that the system simultaneously control the pressure and the flow rate of the air at the patient interface to correspond with a predetermined pressure and a predetermined flow rate, respectively as taught by Aylsworth for the purpose of the gas flow and/or pressure to the nostrils and mouth may be individually controlled which is interpreted as being capable of being done “simultaneously” because mouth the nose and mouth have separately controllable blowers and associated sensors (para. 0053).
Regarding Claim 17, Modified Barnes discloses the method of claim 16, wherein the patient interface(Fig. 1; 30), comprises a projection portion configured to conduct a flow of the air into a naris of the patient and a mask portion configured to apply pressure of the air to the patient (para. 0025; Examiner notes: the patient interface 30 can be a full mask, nasal mask, nasal prongs, … etc.).
Regarding Claim 18, Modified Barnes discloses the method of claim 17, wherein the flow generator (Fig. 1; 20; para. 0023) provides the flow of the air through the projection portion of the patient interface thereby applying pressure of the air to the mask portion of the patient interface (para. 0023; Barnes; Fig. 3; Aylsworth).
Regarding Claim 19, Modified Barnes discloses the method of claim 16 further comprising,
` Barnes does not specifically disclose maintaining, by the one or more controllers, at least one of the predetermined pressure and the predetermined flow rate at a constant value for a period of time.
However, Aylsworth teaches wherein the one or more controllers to maintain at least one of the predetermined pressure and the predetermined flow rate at a constant value for a period of time (Examiner notes: this limitation is functional; para. 0051-0053; the flow rate to the nares may be constantly kept at zero until a predetermined period of time passes which would be the time it takes to detect an obstruction and the pressure applied to the mouth is constant at zero until a predetermined period of time passes which would be the time it takes to detect an obstructing congested nostril which triggers a pressure change to the mouth).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the controllers in Modified Barnes to maintain at least one of the predetermined pressure and the predetermined flow rate at a constant value for a period of time as taught by Aylsworth for the purpose of detecting an obstructing congested nostril (0053).
Regarding Claim 20, Modified Barnes discloses the method of claim 16 further comprising
Modified Barnes does not disclose varying, by the one or more controllers, the predetermined pressure in accordance with a breathing cycle of the patient.
However, Aylsworth teaches wherein at least one or more controllers are further configured to vary the predetermined pressure in accordance with a breathing cycle of the patient (Examiner notes: this limitation is functional, para. 0055; reducing the pressure supplied to the patient during exhalation. The prescribed pressure thus varies over time which corresponds to the breathing cycle – exhalation vs. inhalation).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the controllers in Modified Barnes to vary the predetermined pressure in accordance with a breathing cycle of the patient as taught by Aylsworth for the purpose of reducing the pressure within the patient's airways to ease the patient effort required to exhale and making sure the patient is comfortable (0055).
Regarding Claim 24, Modified Barnes discloses the method of claim 16, wherein controlling the adjustable vent (Fig. 1; 50) comprises adjusting, by the one or more controllers(Fig. 1), a venting characteristic of the adjustable vent in synchrony with the patient's breathing cycle so as to maintain the pressure of the air at the patient interface to correspond with the predetermined pressure (para. 0025).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Barnes and Aylsworth, as applied to claim 4, in view of Barnes different embodiment.
Regarding Claim 6, Modified Barnes discloses the system of claim 4,
Modified Barnes does not specifically disclose wherein at least one of the pressure sensor and the flow rate sensor is located at the patient interface.
However, A different embedment in Barnes teaches wherein at least one of the pressure sensor and the flow rate sensor is located at the patient interface (Fig. 4; para. 0044).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the sensing system in Barnes to include at least one of the pressure sensor and the flow rate sensor is located at the patient interface as taught by other embodiment in Barnes for the purpose of removing the need for this computation (0044).
Claim(s) 9-10 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Barnes and Aylsworth, as applied to claim 1 and 16, in view of Klasek (US 20140144438 A1).
Regarding Claim 9, Modified Barnes discloses the system of claim 1, wherein the simultaneous control of the pressure and the flow rate of the air provides the patient with a positive airway pressure therapy (Fig. 1; para. 0023-0031)
Modified Barnes does not disclose a deadspace therapy.
However, Klasek teaches a method for controlling respiratory therapy comprising providing the patient with a deadspace therapy (para. 0067-0068).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system in Modified Barnes to be able to do deadspace therapy vary as taught by Klasek for the purpose of to change between therapies based on the patient’s respiration cycle (para. 0068).
Regarding Claim 10, Modified Barnes discloses the system of claim 9, wherein the positive airway pressure therapy is a ventilation therapy (para. 0022; Barnes).
Regarding Claim 21, Modified Barnes discloses the method of claim 16, wherein the simultaneous control of the pressure and the flow rate of the air comprises control of a positive airway pressure therapy (para. 0023-0031; Fig. 1)
Modified Barnes does not disclose specifically a deadspace therapy.
However, Klasek teaches a method for controlling respiratory therapy comprising providing the patient with a deadspace therapy (para. 0067-0068).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system in Barnes to be able to do a deadspace therapy vary as taught by Klasek for the purpose of to change between therapies based on the patient’s respiration cycle (para. 0068).
Regarding Claim 22, Modified Barnes discloses the method of claim 21, wherein the positive airway pressure therapy is a ventilation therapy (para. 0022; Barnes).
Claims 11 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Barnes, Aylsworth, as applied to claim 1 and 16, in further view of Fabarik (US 20070273216 A1).
Regarding Claim 11, Modified Barnes disclose he system of claim 1,
Modified Barnes does not disclose wherein the one or more controllers are configured to determine the predetermined pressure and the predetermined flow rate to restrict the predetermined pressure and the predetermined flow rate to a curve of equal efficacy.
However, Farbarik teaches one or more controllers are configured (this limitation is functional) to determine the predetermined pressure and the predetermined flow rate to restrict the predetermined pressure and the predetermined flow rate to a curve of equal efficacy (Figure 5; Examiner notes: The examiner is interpretating this limitation is the parameters are restricted to the curve on a graph; para. 0018, 0052, 0064-0067, 071).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system in Barnes to be able to determine the predetermined pressure and the predetermined flow rate to restrict the predetermined pressure and the predetermined flow rate to a curve of equal efficacy as taught by Farbarik because it is known in the art to determine blower performance between flow rate and pressure; one would want the controller to calculate these parameter to determine the performance of the blower to known if it working property and an application is normally best served by selecting the blower that delivers the desired performance with the best efficiency (0018, 0052, 0064-0067, 0071).
Regarding Claim 23, Modified Barnes disclose the method of claim 16,
Modified Barnes does not disclose further comprising determining, by the one or more controllers, the predetermined pressure and the predetermined flow rate so as to restrict the predetermined pressure and the predetermined flow rate to a curve of equal efficacy.
However, Farbarik teaches one or more controllers are configured (this limitation is functional) to determine the predetermined pressure and the predetermined flow rate to restrict the predetermined pressure and the predetermined flow rate to a curve of equal efficacy (Figure 5-6; Examiner notes: The examiner is interpretating this limitation is the parameters are restricted to the curve on a graph; para. 0018, 0052, 0064-0067, 071).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system in Barnes to be able to determine the predetermined pressure and the predetermined flow rate to restrict the predetermined pressure and the predetermined flow rate to a curve of equal efficacy as taught by Farbarik because it is known in the art to determine blower performance between flow rate and pressure; one would want the controller to calculate these parameter to determine the performance of the blower to known if it working property and an application is normally best served by selecting the blower that delivers the desired performance with the best efficiency (0018, 0052, 0064-0067, 0071).
Claims 12 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Barnes, Aylsworth, as applied to claim 1 and 16, in further view of Witt (US 20130102917 A1).
Regarding Claim 12, Modified Barnes discloses the system of claim 1,
Modified Barnes does not disclose further comprising a variable resistance in the air circuit, wherein the one or more controllers are configured to control one or more of the pressure and the flow rate of the air by adjusting the resistance of the variable resistance.
However, Witt teaches a variable resistance in the air circuit, wherein the one or more controllers are configured to control one or more of the pressure and the flow rate of the air by adjusting the resistance of the variable resistance (para. 0028-0029; Examiner notes; this limitation is functional).
Therefore, it would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to further modify the system of Modified Barnes to include a controller that is configured to control one or more of the pressure and the flow rate of the air by adjusting the resistance of the variable resistance as taught by Witt for purpose to adjust the amount of inhalation air flow in order to draw a negative pressure in variable resistance patient interface device during inspiration and that it can be smoothly adjusted from a high value (para. 0028-0029).
Regarding Claim 25, Modified Barnes discloses the method of claim 16
Modified Barnes does not disclose further comprising adjusting, by the one or more controllers, a resistance of a variable resistance in the air circuit so as to control one or more of the pressure and the flow rate of the air.
However, Witt teaches a variable resistance in the air circuit, wherein the one or more controllers are configured to control one or more of the pressure and the flow rate of the air by adjusting the resistance of the variable resistance (para. 0028-0029; Examiner notes; this limitation is functional).
Therefore, it would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to further modify the system of Modified Barnes to include a controller that is configured to control one or more of the pressure and the flow rate of the air by adjusting the resistance of the variable resistance as taught by Witt for purpose to adjust the amount of inhalation air flow in order to draw a negative pressure in variable resistance patient interface device during inspiration and that it can be smoothly adjusted from a high value (para. 0028-0029).
Claim(s) 13 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Barnes and Aylsworth, as applied to claim 1 and 16, in view of Bassin (US 20070163590 A1).
Regarding Claim 13, Modified Barnes discloses the system of claim 1,
Modified Barnes does not specifically disclose wherein a controller of the one or more controllers is configured to compute a target ventilation based on anatomical deadspace information and a deadspace therapy reduction value.
However, Bassin teaches controlling ventilation comprising: calculating, in a controller of the one or more controllers (Fig. 1; 15), a target ventilation based (para. 0029; Examiner notes: a controlled ventilation) on anatomical deadspace information and a deadspace therapy reduction value (para. 0029, 0097: Examiner notes: weight as anatomical deadspace information in order to derive a value to subtract from the target ventilation, this limitation is functional).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system in Modified Barnes with the controller step of calculating ventilation based on anatomical deadspace as taught by Bassin in order to measure alveolar ventilation (para. 0095) which requires accounting for the deadspace which is always present in a patient’s airways (para. 0029).
Regarding Claim 26, Modified Barnes discloses the method of claim 16,
Modified Barnes does not disclose further comprising calculating, in the one or more controllers, a target ventilation based on anatomical deadspace information and a deadspace therapy reduction value.
However, Bassin teaches controlling ventilation comprising: calculating, in a controller of the one or more controllers (Fig. 1; 15), a target ventilation based (para. 0029; Examiner notes: a controlled ventilation) on anatomical deadspace information and a deadspace therapy reduction value (para. 0029, 0097: Examiner notes: weight as anatomical deadspace information in order to derive a value to subtract from the target ventilation, this limitation is functional).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system in Modified Barnes with the controller step of calculating ventilation based on anatomical deadspace as taught by Bassin in order to measure alveolar ventilation (para. 0095) which requires accounting for the deadspace which is always present in a patient’s airways (para. 0029).
Claim 14 and 27 is rejected under 35 U.S.C. 103 as being unpatentable over Barnes and Aylsworth, as applied to claim 1 and 16, in view of Fisher (US 20070062531 A1).
Regarding Claim 14, Modified Barnes discloses the system of claim 1,
Modified Barnes does not specifically teach wherein a controller of the one or more controllers is configured to generate a cardiac output estimate by controlling a step change in the predetermined flow rate of the air and determining a change in a measure of ventilation in relation to the step change.
However, Fisher teaches a method of determining cardiac output comprising: generating, in a controller of the one or more controllers (para. 0181-0182; Examiner notes: gas analyzer and flow controller), a cardiac output estimate (para. 0284) by controlling a step change in the predetermined flow rate of the air (para. 0288; Examiner notes: imposing a step change in ventilation VA and the next step in para. 0289 determines cardiac output, Q. para. 0003 defines cardiac output as the variable Q) and determining a change in a measure of ventilation in relation to the step change (para. 0288 discloses calculating VCO2 which is a measure of ventilation – the flow of CO2 out of the lungs; para. 0023).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system in Modified Barnes to include a controller of the one or more controllers is configured to generate a cardiac output estimate by controlling a step change in the predetermined flow rate of the air and determining a change in a measure of ventilation in relation to the step change as taught by Fisher for the purpose non-invasively monitor cardiac output (para. 0006) for high risk patients (para. 0008-0010]), during major surgery (para. 0012) and diagnostic purposes (para. 0014).
Regarding Claim 27, Modified Barnes discloses the method of claim 16,
Modified Barnes does not disclose further comprising generating, in the one or more controllers, a cardiac output estimate by controlling a step change in the predetermined flow rate of the air and determining a change in a measure of ventilation in relation to the step change.
However, Fisher teaches a method of determining cardiac output comprising: generating, in a controller of the one or more controllers (para. 0181-0182; Examiner notes: gas analyzer and flow controller), a cardiac output estimate (para. 0284) by controlling a step change in the predetermined flow rate of the air (para. 0288; Examiner notes: imposing a step change in ventilation VA and the next step in para. 0289 determines cardiac output, Q. para. 0003 defines cardiac output as the variable Q) and determining a change in a measure of ventilation in relation to the step change (para. 0288 discloses calculating VCO2 which is a measure of ventilation – the flow of CO2 out of the lungs; para. 0023).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system in Barnes to include a controller of the one or more controllers is configured to generate a cardiac output estimate by controlling a step change in the predetermined flow rate of the air and determining a change in a measure of ventilation in relation to the step change as taught by Fisher for the purpose non-invasively monitor cardiac output (para. 0006) for high risk patients (para. 0008-0010]), during major surgery (para. 0012) and diagnostic purposes (para. 0014).
Claims 15 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Barnes, Aylsworth, and Fisher, as applied to claim 14 and 27, in further view of Gardon et al. (CA 3065994 A1), hereafter as Gardon.
Regarding Claim 15, Modified Barnes discloses the system of claim 14,
Modified Barnes does not disclose wherein the controller of the one or more controllers is configured to initiate control of the step change in the predetermined flow rate of the air in response to a detection of sleep.
However, Gradon teaches wherein the controller of the one or more controllers is configured to initiate control of the step change (Page 20, line 12-Page 24 line 12: Fig. 9c) in the predetermined flow rate (Examiner notes: pressure and flow are intimately related in fluid dynamics) of the air in response to a detection of hypopnea or airway obstruction.
Therefore, it would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to further modify one of the controllers of Modified Barnes to include a controller that is configured to initiate control of the step change in the predetermined flow rate of the air in response to a detection of sleep as taught by Gradon for the purpose of giving the patient the needed parameters if there is a partial airway obstruction, an apnoea, or a hypopnea with partial airway obstruction has occurred (Page 22 lines 4-11).
Regarding Claim 28, Modified Barnes discloses the method of claim 27,
Modified Barnes does not disclose further comprising initiating, by the one or more controllers, the controlling of the step change in the predetermined flow rate of the air in response to a detection of sleep.
However, Gradon teaches further comprising initiating, by the one or more controllers, the controlling of the step change in the predetermined flow rate (Examiner notes: pressure and flow are intimately related in fluid dynamics) of the air in response to a detection of hypopnea or airway obstruction during sleep (Page 20, line 12-Page 24 line 12: Fig. 9c).
Therefore, it would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to further modify one of the controllers of Modified Barnes to include a controller that is configured to initiate control of the step change in the predetermined flow rate of the air in response to a detection of sleep as taught by Gradon for the purpose of giving the patient the needed parameters if there is a partial airway obstruction, an apnoea, or a hypopnea with partial airway obstruction has occurred (Page 22 lines 4-11).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim 1-2, 7-11, and 13-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18, 19, 24, 25, 28, 29, 34-37 of U.S. Patent No. US 11318266 B2, hereafter as ‘266, in view of Barnes. Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all the elements of claims mirror each other.
Regarding Claim 1, ‘266 discloses a system for delivery of a flow of air to a patient's airways comprising: a flow generator configured to provide air to a patient via and a patient interface; and one or more controllers configured to: determine a pressure and a flow rate of the air being provided to the patient via the patient interface with a plurality of sensors; and control the flow generator and the adjustable vent so as to simultaneously control the pressure and the flow rate of the air at the patient interface to correspond with a predetermined pressure and a predetermined flow rate, respectively (Claim 18).
‘266 does not disclose specifically an air circuit and an adjustable vent.
However, Barnes teaches an air circuit (Fig. 1; 40; para. 0022) and an adjustable vent (Fig. 1; 50; para. 0028).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify ‘266 to include an air circuit and an adjustable vent as taught by Barnes for the purpose of selectively adjusts the vent valve to maintain constant flow (para. 0028).
Regarding Claim 2, Modified ‘266 comprising the system of claim 1, (Claim 19).
Regarding Claim 7, Modified ‘266 comprising the system of claim 1, (Claim 24).
Regarding Claim 8, Modified ‘266 comprising the system of claim 1, (Claim 25).
Regarding Claim 9, Modified ‘266 comprising the system of claim 1, (Claim 28).
Regarding Claim 10, Modified ‘266 comprising the system of claim 1, (Claim 29).
Regarding Claim 11, Modified ‘266 comprising the system of claim 1, (Claim 18, 37).
Regrading Claim 13, Modified ‘266 comprising the system of claim 1, (Claim 34).
Regrading Claim 14, Modified ‘266 comprising the system of claim 1, (Claim 35).
Regrading Claim 15, Modified ‘266 comprising the system of claim 1, (Claim 36).
Claim 4-5 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 and 23 of ‘266 and Barnes, as applied to claim 2, in view of Aylsworth.
Regarding Claim 4, Modified ‘266 comprising the system of claim 2, (Claim 18, Claim 23).
Modified ‘266 does not disclose specifically a flow rate sensor for determining a measured flow rate of the air through the projection portion of the patient interface.
However, Aylsworth teaches a flow rate sensor for determining a measured flow rate of the air through the projection portion of the patient interface (Fig. 3, flow sensors 34, 42, 43 and pressure transducers 36, 44, 45; para. 0039).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the sensing system in Modified ‘266 to include a flow rate sensor for determining a measured flow rate of the air through the projection portion of the patient interface as taught by Aylsworth for the purpose of the gas flow and/or pressure to the nostrils and mouth may be individually controlled which is interpreted as being capable of being done “simultaneously” because mouth the nose and mouth have separately controllable blowers and associated sensors (para. 0053).
Regarding claim 5, Modified ‘266 comprising the system of claim 4, (Claim 23).
Claim 6 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 and 23 of ‘266 Barnes, and Aylsworth, as applied to claim 4, in view of Another embodiment of Barnes.
Regarding Claim 6, Modified ‘266 comprising the system of claim 4,
Modified ‘266 does not specifically disclose wherein at least one of the pressure sensor and the flow rate sensor is located at the patient interface.
However, a different embedment in Barnes teaches wherein at least one of the pressure sensor and the flow rate sensor is located at the patient interface (Fig. 4; para. 0044).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the sensing system in’266 to include at least one of the pressure sensor and the flow rate sensor is located at the patient interface as taught by other embodiment in Barnes for the purpose of removing the need for this computation (0044).
Claim 12 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of ‘266 and Barnes, as applied to claim 1, in view of Witt.
Regarding Claim 12, ‘Modified ‘266 comprising the system of claim 1,
Modified ‘266 does not specifically disclose further comprising a variable resistance in the air circuit, wherein the one or more controllers are configured to control one or more of the pressure and the flow rate of the air by adjusting the resistance of the variable resistance.
However, Witt teaches a variable resistance in the air circuit, wherein the one or more controllers are configured to control one or more of the pressure and the flow rate of the air by adjusting the resistance of the variable resistance (para. 0028-0029; Examiner notes; this limitation is functional).
Therefore, it would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to further modify the system of Modified ‘266 to include a controller that is configured to control one or more of the pressure and the flow rate of the air by adjusting the resistance of the variable resistance as taught by Witt for purpose to adjust the amount of inhalation air flow in order to draw a negative pressure in variable resistance patient interface device during inspiration and that it can be smoothly adjusted from a high value (para. 0028-0029).
Claim 16-18, 20-24, and 26-28 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7-8, 10, 12-13, and 14-17, of U.S. Patent No. US 11318266 B2, hereafter as ‘266, in view of Barnes. Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all the elements of claims mirror each other.
Regarding Claim 16, ’266 discloses a method for controlling a supply of air to a patient's airways for a respiratory therapy, the method comprising: identifying, by one or more controllers, a predetermined pressure and a predetermined flow rate of the air to be provided to a patient via a patient interface; determining, with a plurality of sensors, a pressure and a flow rate of the air being provided to the patient via the patient interface; and controlling, by the one or more controllers, a flow generator configured to provide the air to the patient interface, so as to simultaneously control the pressure and the flow rate of the air at the patient interface to correspond with the predetermined pressure and the predetermined flow rate, respectively.
‘266 does not disclose specifically an air circuit and an adjustable vent.
However, Barnes teaches an air circuit (Fig. 1; 40; para. 0022) and an adjustable vent (Fig. 1; 50; para. 0028).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify ‘266 to include an air circuit and an adjustable vent as taught by Barnes for the purpose of selectively adjusts the vent valve to maintain constant flow (para. 0028).
Regarding Claim 17, Modified ‘266 comprising the method of claim 16, (Claim 3).
Regarding Claim 18, Modified ‘266 comprising the method of claim 16, (Claim 3, 7).
Regarding Claim 20, Modified ‘266 comprising the method of claim 16, (Claim 8).
Regarding Claim 21, Modified ‘266 comprising the method of claim 16, (Claim 12).
Regarding Claim 22, Modified ‘266 comprising the method of claim 16, (Claim 13).
Regrading Claim 23, Modified ‘266 comprising the method of claim 16, (Claim 1, 17).
Regrading Claim 24, Modified ‘266 comprising the method of claim 16, (Claim 10)
‘266 does not specifically disclose wherein controlling the adjustable vent comprises adjusting, by the one or more controllers, a venting characteristic of the adjustable vent in synchrony with the patient's breathing cycle so as to maintain the pressure of the air at the patient interface to correspond with the predetermined pressure.
However, Barnes discloses wherein controlling the adjustable vent (Fig. 1; 50) comprises adjusting, by the one or more controllers (Fig. 1), a venting characteristic of the adjustable vent in synchrony with the patient's breathing cycle so as to maintain the pressure of the air at the patient interface to correspond with the predetermined pressure (para. 0025).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify ‘266 to include controlling the adjustable vent as taught by Barnes for the purpose of selectively adjusts the vent valve to maintain constant flow (para. 0028).
Regrading Claim 26, Modified ‘266 comprising the method of claim 16, (Claim 14).
Regrading Claim 27, Modified ‘266 comprising the method of claim 16, (Claim 15).
Regrading Claim 28, Modified ‘266 comprising the method of claim 16, (Claim 16).
Claim 19 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘266, Barnes, as applied to claim 16, in view of Aylsworth.
Regarding Claim 19, Modified ‘266 comprising the method claim 16,
Modified ‘266 does not specifically disclose maintaining, by the one or more controllers, at least one of the predetermined pressure and the predetermined flow rate at a constant value for a period of time.
However, Aylsworth teaches wherein the one or more controllers to maintain at least one of the predetermined pressure and the predetermined flow rate at a constant value for a period of time (Examiner notes: para. 0051-0053; the flow rate to the nares may be constantly kept at zero until a predetermined period of time passes which would be the time it takes to detect an obstruction and the pressure applied to the mouth is constant at zero until a predetermined period of time passes which would be the time it takes to detect an obstructing congested nostril which triggers a pressure change to the mouth).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the controllers in Modified ‘266 to maintain at least one of the predetermined pressure and the predetermined flow rate at a constant value for a period of time as taught by Aylsworth for the purpose of detecting an obstructing congested nostril (0053).
Claim 25 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘266 and Barnes, as applied to claim 16, in view of Witt.
Regarding Claim 25, ‘Modified ‘266 comprising the method of claim 16,
Modified ‘266 does not specifically disclose further comprising a variable resistance in the air circuit, wherein the one or more controllers are configured to control one or more of the pressure and the flow rate of the air by adjusting the resistance of the variable resistance.
However, Witt teaches a variable resistance in the air circuit, wherein the one or more controllers are configured to control one or more of the pressure and the flow rate of the air by adjusting the resistance of the variable resistance (para. 0028-0029; Examiner notes; this limitation is functional).
Therefore, it would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to further modify the system of Modified ‘266 to include a controller that is configured to control one or more of the pressure and the flow rate of the air by adjusting the resistance of the variable resistance as taught by Witt for purpose to adjust the amount of inhalation air flow in order to draw a negative pressure in variable resistance patient interface device during inspiration and that it can be smoothly adjusted from a high value (para. 0028-0029).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references. Other prior art of particular note include: Wood (US 6478026 B1; Figs. 7, 10-12), Hernandez (US 20060266361 A1; Figs. 7 and 13) and Lee (US 4915105 A; Figs. 1-2).
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/MAAP ELLABIB/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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